Hire the best Biotechnology Regulatory Affairs professionals

Check out Biotechnology Regulatory Affairs professionals with the skills you need for your next job.
  • $89 hourly
    My name is Rebecca, and I am an experienced, results-driven Regulatory Affairs Specialist. With over 6 years of hands-on regulatory expertise across a range of industries—most notably the medical device sector—I specialise in ensuring that companies achieve unparalleled compliance while navigating the complexities of global regulations. My mission is simple: to take the burden of regulatory requirements off your shoulders and drive your success in any regulated market. Why Work With Me? I combine exceptional technical knowledge, a passion for the intricacies of regulatory law, and a proven ability to adapt to any regulated industry. Whether you need support in medical devices, pharma, biotechnology, or other industries requiring rigorous compliance, I have the expertise to deliver solutions tailored to your needs. My clients span start-ups, established corporations, and global market leaders—all of whom trust me to lead them through the challenges of compliance and quality assurance. Key Highlights of My Expertise: Global Regulatory Compliance: Proficient in FDA submissions, EU MDR compliance, CE marking, ISO certifications, and more. Extensive experience in regulated industries, including medical devices, pharmaceuticals, consumer goods, and software as a medical device (SaMD). Skilled in adapting to the unique demands of each regulatory framework to ensure seamless product launches. Quality Management Systems (QMS): Design, implementation, and auditing of ISO 13485-compliant QMS for medical devices and other regulated industries. Internal auditing expertise, ensuring the highest standards for safety, risk management, and post-market surveillance. Experience with CAPA (Corrective and Preventive Actions) and MDSAP standards for quality excellence. Technical and Regulatory Writing: Creation of FDA-ready technical documentation, Declarations of Conformity, Instructions for Use (IFUs), and product labelling. Writing marketing materials, blogs, and whitepapers to communicate complex compliance topics clearly and effectively. Developed 100+ pages of regulatory documentation for AdvaCare Pharma, leading to my appointment as a Board Member of Medical Advisors. Adaptability Across Regulated Markets: My expertise translates seamlessly to consumer products, biotech, cosmetics, environmental regulations, and more. Well-versed in providing compliance solutions tailored to specific industries' needs and timelines. My Passion & Mission: Compliance is more than a requirement—it’s an opportunity to build trust, protect consumers, and drive innovation. I am deeply passionate about regulatory affairs because I know that meticulous adherence to standards doesn’t just ensure safety—it opens doors to global markets, ensures sustainable growth, and builds long-term reputations. As an active member of TOPRA and RAPS, I stay at the forefront of industry developments and emerging regulations. This allows me to bring cutting-edge insights and proactive strategies to every project I undertake. Certifications & Qualifications: ISO 13485:2016 Lead Auditor – British Standards Institute (BSI). MDSAP Internal Quality Auditor Certification. Masters in Medical Device Regulatory Affairs (MSc) with First Class Honors. Extensive training in FDA CFR Part 820, IEC 60601-1, and other critical compliance standards. Industries I Support: Medical Devices: From Class I to III, including SaMD (Software as a Medical Device). Pharmaceuticals: Regulatory documentation, quality systems, and compliance guidance. Consumer Goods: Adherence to safety regulations and quality standards. Biotechnology: Compliance strategies for innovative and cutting-edge technologies. Cosmetics and Personal Care: Navigating global regulations, including EU and FDA requirements. What Clients Say About Me: "Rebecca is a regulatory affairs specialist with years of experience in the medical device sector. Her expertise spans regulatory compliance in major markets, including the US, EU and Asia, and the implementation of Quality Management Systems (QMS) compliant with global standards. Rebecca excels in translating complex technical information into clear, accessible content. As an active member in TOPRA & RAPS and position as Lead Auditor, she has experience in every aspect of regulatory affairs and quality assurance. Rebecca’s contributions to enhancing medical device compliance underscores her exceptional ability in providing critical medical information effectively. " – AdvaCare Pharma Let’s Work Together: If you’re looking for a trusted partner who will not only ensure compliance but also provide strategic insight, I’m here to help. Whether you need help with FDA submissions, ISO certifications, regulatory audits, or compliance content, I’ll bring clarity, precision, and results to your project. Let’s connect to discuss how I can contribute to your success! Rebecca
    vsuc_fltilesrefresh_TrophyIcon Biotechnology Regulatory Affairs
    SEO Content
    Blog Writing
    Content Writing
    Technical Writing
    Article Writing
    Copywriting
    SEO Writing
    Pharmaceutical Industry
    Medical Writing
    Quality Audit
    ISO 9001
    Regulatory Compliance
    Quality Management System
    Medical Device
    Blog Content
  • $85 hourly
    Experienced professional in delivering organized, reliable, and successful outcomes in areas related to biological research, biological target identification, and drug discovery. Project management skills related to regulatory affairs, preclinical project development, and general drug discovery.
    vsuc_fltilesrefresh_TrophyIcon Biotechnology Regulatory Affairs
    Pharmaceuticals
    Pharmaceutical Industry
    Regulatory Intelligence
    Regulatory Compliance
    Life Science
    Science
    Project Management Professional
    Biology Consultation
    Molecular Biology
    Cellular Biology
    Biology
    Drug Regulation
    Biotechnology
    Project Management
    Product Development
  • $150 hourly
    Greetings! I am a certified Regulatory consultant with over 15 years of experience managing pharmaceutical, biologics, medical device (including SaMD), and combination product projects. I specialize in helping companies navigate the complex landscape of FDA regulations to ensure that products are safe, effective, and compliant. I'm Top Rated Plus with a 100% Job Success score. What I Offer: • Expertise in compiling, reviewing, and submitting FDA applications like 510(k)s, INDs, and NDAs. • Human factors engineering and usability engineering expertise. • Extensive experience in quality assurance, cGMP, and ISO 13485. • Conducting internal audits to ensure FDA compliance. • Risk assessment and mitigation strategies. • Regulatory documentation and label review. • Liaison between your team and regulatory agencies. Why Choose Me: • Proven track record of successful FDA submissions. • Strong project management skills to ensure timely project completion. • Excellent communication skills, both written and verbal. • Current with the latest FDA guidelines and updates. • Passionate about bringing safe and effective products to market. I'm flexible and reliable, and I pride myself on meticulous attention to detail. My ultimate goal is to help your company mitigate risks and expedite the time-to-market for your products. I'm looking forward to bringing my expertise to your project!
    vsuc_fltilesrefresh_TrophyIcon Biotechnology Regulatory Affairs
    Quality Assurance
    Usability Testing
    Process Improvement
    QA Management
    Regulatory Intelligence
    Medical Device
    Internal Auditing
    Elearning
    Human Factors Analysis
    Continuous Improvement
    Regulatory Compliance
    Compliance
    Business Analysis
  • $15 hourly
    Seasoned Virtual Assistant and Digital Marketing Expert with over 4 years of hands-on experience, I am dedicated to empowering businesses to achieve their full potential. I have successfully completed over 10,000 hours of work, helping more than 100 diverse businesses streamline their operations, enhance their online presence, and drive growth. Top Highlights - Top Rated Plus Freelancer - 10,000+ Hours Worked - 100+ Businesses Helped - 4+ Years of Experience Are you ready to take your business to the next level? Whether you need a strategic marketing boost or seamless virtual assistance, I’m here to make it happen. With over four years of experience as a Top Rated Plus freelancer, I’ve worked more than 10,000 hours helping 100+ businesses achieve their goals and scale their success. Why You’ll Want to Work with Me: Virtual Assistant Expertise: Need someone to streamline your day-to-day operations, handle client communication, or manage your projects with precision? I’ve got you covered. I bring a proactive approach to virtual assistance, ensuring that your business runs smoothly and efficiently. Whether it's calendar management, email support, or research tasks, I take care of the details so you can focus on the big picture. Marketing Magic: From creating high-converting ads on platforms like Amazon and Meta to crafting content that resonates with your audience, I specialize in driving growth through smart, data-driven marketing strategies. I’ve helped clients double their sales, increase their ROI, and build brand loyalty with targeted campaigns that deliver results. Customized Solutions: No two businesses are the same, and neither are my solutions. I take the time to understand your unique needs and challenges, tailoring my services to fit your specific goals. Whether it’s developing a marketing plan from scratch or stepping in as your right-hand assistant, I provide the exact support you need, when you need it. Results That Matter: Imagine freeing up hours of your time while seeing tangible growth in your business. That’s what I deliver. My clients have seen significant improvements in key performance indicators, from increased web traffic and social media engagement to streamlined processes that save time and reduce stress. Let’s Make Your Business Shine If you're looking for a reliable, results-driven partner who can elevate your business through expert marketing and top-notch virtual assistance, let's connect! Send me a message today, and let's start turning your business goals into reality.
    vsuc_fltilesrefresh_TrophyIcon Biotechnology Regulatory Affairs
    Meeting Scheduling
    Communications
    Client Management
    Brand Research
    CRM Development
    Digital Marketing
    Email Communication
    Project Management
    Social Media Content Creation
    Administrative Support
    WordPress e-Commerce
    Social Media Marketing
    Social Media Management
    Amazon Listing Optimization
    Search Engine Optimization
  • $12 hourly
    I am a TOP RATED VA. I started my VA career here in November 2013, with minimal and part-time jobs, and decided to be a full-time VA on May 2019 onwards. CERTIFIED BOOKKEEPER COST ACCOUNTING PROFESSIONAL CHARTERED FINANCIAL MANAGEMENT ANALYST CERTIFIED PAYROLL SPECIALIST CERTIFIED INTERNAL AUDIT SPECIALIST CHARTERED TAX PROFESSIONAL Accounting/Bookkeeping Software: Quickbooks Desktop, Quickbooks Online, Xero, Wave, Zoho Books Certifications: Quickbooks Desktop Certified, Quickbooks Online Certified, Xero Certified Advisor, Xero Partner Skills: Standards of accounting, General business knowledge, Software proficiency, Data analysis, Problem-solving Property Management Companies Software: Appfolio, Buildium, Innago Certifications: Appfolio Leasing Certification, Appfolio Accounting Certification Skills: Understanding landlord-tenant laws and regulations, Handling maintenance requests and repairs, Marketing properties, Managing tenants/rents/properties, Service Companies Software: Servicem8, Deputy Skills: Service Quotations/Estimates, Accepting Service Requests, Assigning Service Requests to the team/personnel, Making follow-up about the progress of the Service Requests, Sending Service Request Reports to the clients, Billing and Collecting Payment from Clients eCommerce Companies Software: Magento Digital eCommerce, Amazon Seller, Dear, Shipfusion Skills: Order Management, Inventory Management, Requisition/Purchase, Customer Service via email responses Other Niche/Skills Software: Mailchimp, Klaviyo, Hubspot, Canva, VSDC, WordPress, Weebly, Trello, Zoho Projects, Asana, Bootcamp, Office 360, Google GSuite, Zoho One, Certifications: Google Fundamentals of Digital Marketing, Hubspot Digital Marketing, Hubspot Social Media, Hubspot SEO Certified, Hubspot Email Marketing Skills: Social Media Management, Email Marketing, Photo Editing, Video Editing, Website Design, Project/Task management, Calendar Management
    vsuc_fltilesrefresh_TrophyIcon Biotechnology Regulatory Affairs
    Basecamp
    Xero
    Property Management
    Buildium
    Trello
    Bookkeeping
    Email Marketing
    Ecommerce
    AppFolio
    Google Workspace
    Social Media Marketing
    Intuit QuickBooks
  • $15 hourly
    ★ 5+ years of experience ★ 5 Stars rating and reviews received Over 5 years experience in Regulatory Affairs, V&V and technical submissions for a range of medical devices, including orthopaedics, active implantable and novel, high-risk electromechanical systems. Responsible for authoring several 510(k) submissions for the FDA, including all relevant attachments and reports (clinical evaluations, FMEA risk management files, biocompatibilty reporting, process validations, labeling and packaging etc). Similarly, have authored several technical files and design dossiers for CE marking of Class IIa, IIb and Class III devices. Handled all subsequent follow-ups and questions from Notified Bodies, including on-site audits from both the FDA and BSI. Participated in pres-sub activities with the FDA for novel high-risk implants in the design phase, to establish regulatory pathway to First In-Human trials and subsequent PMA. Achieved and maintained registration of products in a range of jurisdictions including EU, US, Canada, Australia, Israel, Chile and Japan. Familiar with the application of a range of standards including ISO 13485, ISO 14971, IEC 60601, FDA 21 CFR Part 820, as well as upcoming changes in the new EU MDR. Well versed in the development and lodgement of Regulatory Files, and can complete activities such as literature searches, clinical evaluations ,predicate device comparisons, development of SOP's and other QMS documentation, as well as validations for processes such as sterilization (gamma and EtO), packaging, and Human Factors Engineering studies. I look forward to working with you! Thanks!
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    Regulatory Compliance
    Quality Management System
    Medical Writing
  • $90 hourly
    🩺 𝗣𝗵𝗗 & 𝗠𝗗. 𝟴+ 𝘆𝗲𝗮𝗿𝘀 𝗼𝗳 𝘀𝘁𝗮𝘁𝘀 𝗼𝗯𝘀𝗲𝘀𝘀𝗶𝗼𝗻. 📊 𝟭𝟬𝟬+ 𝗽𝗿𝗼𝗷𝗲𝗰𝘁𝘀 𝗺𝗲𝘁𝗶𝗰𝘂𝗹𝗼𝘂𝘀𝗹𝘆 𝗰𝗼𝗺𝗽𝗹𝗲𝘁𝗲𝗱. 𝗔𝗹𝘄𝗮𝘆𝘀 𝗼𝗻-𝘁𝗶𝗺𝗲. 𝗔𝘁𝘁𝗲𝗻𝘁𝗶𝗼𝗻 𝘁𝗼 𝗱𝗲𝘁𝗮𝗶𝗹 𝗮𝗻𝗱 𝗲𝘅𝗰𝗲𝗽𝘁𝗶𝗼𝗻𝗮𝗹 𝗾𝘂𝗮𝗹𝗶𝘁𝘆 𝗳𝗼𝗰𝘂𝘀. 𝗠𝘆 𝗴𝗲𝗻𝗶𝘂𝘀 𝘇𝗼𝗻𝗲 𝗶𝘀 𝗲𝘅𝘁𝗿𝗮𝗰𝘁𝗶𝗻𝗴 𝗶𝗻𝘀𝗶𝗴𝗵𝘁𝘀 𝗺𝘆 𝗰𝗼𝗺𝗽𝗲𝘁𝗶𝘁𝗼𝗿𝘀 𝗺𝗶𝘀𝘀. 🎯 Hi I’m Amer and I excel at supporting US 🇺🇸 and worldwide 🌎 based healthcare projects with all of their biostatistician, research and data analyst needs. I’m currently focused on working on long-term projects. ☑️ As a result of working together you can expect with the data provided or collected I can tell you exactly what was learned that was statistically significant or not. 📞 Please invite me to your project on Upwork if you would like to schedule a complimentary consultation call together. 📞 ❝ 𝘿𝙧 𝘼𝙢𝙚𝙧 𝙞𝙨 𝙖 𝙧𝙤𝙘𝙠𝙨𝙩𝙖𝙧 𝙙𝙖𝙩𝙖 𝙨𝙘𝙞𝙚𝙣𝙩𝙞𝙨𝙩 𝙖𝙣𝙙 𝙥𝙝𝙮𝙨𝙞𝙘𝙞𝙖𝙣 𝙗𝙞𝙤𝙨𝙩𝙖𝙩𝙞𝙘𝙞𝙖𝙣. 𝙄𝙩 𝙬𝙖𝙨 𝙖 𝙥𝙡𝙚𝙖𝙨𝙪𝙧𝙚 𝙬𝙤𝙧𝙠𝙞𝙣𝙜 𝙬𝙞𝙩𝙝 𝙮𝙤𝙪 𝘿𝙧 𝘼𝙢𝙚𝙧 𝙖𝙣𝙙 𝙬𝙚 𝙡𝙤𝙤𝙠 𝙛𝙤𝙧𝙬𝙖𝙧𝙙 𝙩𝙤 𝙘𝙤𝙣𝙩𝙞𝙣𝙪𝙞𝙣𝙜 𝙩𝙝𝙞𝙨 𝙧𝙚𝙡𝙖𝙩𝙞𝙤𝙣𝙨𝙝𝙞𝙥. 𝘿𝙚𝙡𝙞𝙫𝙚𝙧𝙚𝙙 𝙤𝙣 𝙩𝙞𝙢𝙚, 𝙨𝙘𝙤𝙥𝙚 𝙖𝙣𝙙 𝙫𝙚𝙧𝙮 𝙬𝙚𝙡𝙡 𝙘𝙤𝙢𝙢𝙪𝙣𝙞𝙘𝙖𝙩𝙚𝙙. 𝘼 𝙩𝙧𝙪𝙚 𝙚𝙭𝙥𝙚𝙧𝙩 𝙞𝙣 𝙝𝙞𝙨 𝙛𝙞𝙚𝙡𝙙. ❞
    vsuc_fltilesrefresh_TrophyIcon Biotechnology Regulatory Affairs
    SAS
    Machine Learning
    Predictive Analytics
    Stata
    Data Analysis
    Clinical Trial
    Clinical Trial Management System
    Medical Editing
    Statistical Analysis
    Quantitative Analysis
    Research Methods
    Data Science
    R
    Apache Spark
    Python
  • $140 hourly
    I am a skilled and experienced biomedical engineer specializing in the design and development of medical devices/medical technologies. I have worked in the medical technology industry for over a decade and have a Bachelors of Engineering and Masters of Science in biomedical engineering. With extensive expertise in design quality, quality assurance, and regulatory affairs within the industry, I am well-equipped to handle any challenges that may arise. Throughout my career, I have successfully worked with both large medical device corporations and startups, gaining invaluable insights into the FDA submission process and the specific requirements based on technology risk. I possess a thorough understanding of how to navigate the complex regulatory landscape and bring medical devices through the approval process. My previous accomplishments include the development and maintenance of robust quality systems, leading design quality projects for Class II/III medical devices by employing risk analysis and design control strategies. Additionally, I have extensive experience in interacting with the FDA throughout the pre-submission and 510(k)/PMA/De Novo submission processes, ensuring compliance and smooth communication. Furthermore, I am well-versed in auditing quality systems based on 21 CFR 820 and ISO 13485. This ensures that my clients can confidently rely on my expertise to meet and exceed regulatory requirements and industry best practices. If you are in need of a highly skilled MedTech consultant with a proven track record and in-depth knowledge of the medical technology industry, I am confident that my qualifications make me the ideal candidate for your project. Let's collaborate to bring your ideas to life and transform healthcare for the better.
    vsuc_fltilesrefresh_TrophyIcon Biotechnology Regulatory Affairs
    Product Development
    Design & Usability Research
    Design Validation
    Technical Writing
    Commercialization
    Risk Analysis
    Quality Management System
    Process Development
    Communication Skills
    Professional Tone
    Regulatory Compliance
    Failure Mode & Effects Analysis
    Biomedical Engineering
    Medical Device
  • $120 hourly
    Over 15 years of experience with medical device and pharmaceutical regulatory compliance and quality systems. Areas of expertise include: -21 CFR 820 (Medical Device GMP) -21 CFR 211 (Pharmaceutical cGMP) -21 CFR 111 (Dietary Supplements) -ISO13485: 2016 (Medical Device Quality Systems) -Internal auditing -FDA responses/corrective actions for 483s/Warning Letters -Gap assessment and remediation -Writing and revising policies and procedures for quality system compliance -Regulatory and claim substantiation reviews of labeling and marketing materials -Design control regulatory team member -Risk assessments -Regulatory due-diligence for acquisitions -FDA preparedness training -Supplier management -Complaint management and reporting to regulatory agencies -3rd party audit responses and CAPA development -Recall coordinator -UDI implementation -California Prop65 compliance -State Board of Pharmacy licensure for manufacturers/wholesalers -NAFTA COO Certifications, VA Letters of Supply, Conflict Minerals Surveys, FDA Certificates for Foreign Governments applications -FDA Medical Device Establishment registration and Device Listings -Deviation investigation and risk assessment/mitigation -ABC (American Board for Prosthetics and Orthotics) Facility Accreditation/Medicare Supplier Accreditation (developed quality system to ensure compliance; lead audits) Proficiency in the following: -Trackwise -Salesforce -Word -Excel -Powerpoint -Access -Adobe Specializing in the development of lean, efficient and compliant solutions to address FDA and international regulatory requirements.
    vsuc_fltilesrefresh_TrophyIcon Biotechnology Regulatory Affairs
    Project Risk Management
    Vendor Management
    Company Policy
    Medical Device
    Document Review
    Document Management System
    Pharmaceutical Industry
    Internal Auditing
    Regulatory Compliance
    Procedure Manual
  • $70 hourly
    I have successfully obtained over 60 510(K) clearances from the FDA for a vast range of medical devices. I can assist you with your 510(k), Q-Sub (Pre-Sub), or IDE submissions, along with any other medical device documentation needs. I am also very experienced in helping to register and list Class 1 exempt medical devices with the FDA. I am insured, and I can guarantee that you will be satisfied with the value that I provide or you won't be charged. I can also help you with On-Line Training, Process Validation, Design Control Activities, Document Creation and Review. Lastly, I can provide sound advice and answers to your regulatory concerns and questions based upon my over 25 years of experience. My business model is built upon being fast, good, and satisfying clients! Please allow me to become your Trusted Advisor.
    vsuc_fltilesrefresh_TrophyIcon Biotechnology Regulatory Affairs
    Project Plans
    Internal Auditing
    Quality Assurance
    Software Testing
    Quality Control
    Project Delivery
    Medical Device
    Regulatory Compliance
    Technical Writing
    Medical Device User Manual
  • $40 hourly
    If you are looking for a contractor for medical and health related writing, you should choose one with a broad base of knowledge and the ability to develop finished pieces of work from your ideas or visions. My professional background has provided me extensive organizational and managerial experiences that allow me to communicate with my clients to establish clear project goals. I offer over twenty years of clinical practice, medical research, progressive business development, project management, grant writing and adult education experience. It is because of this, that I feel these experiences uniquely qualify me to deliver a well executed, quality finished product. With the ability to write highly technical pieces and general language for the layman, I have writing skills that appeal to many different clients. My writing skills are an excellent source for all of your business or personal writing needs. I have a BS in Microbiology, an MS in Nursing and I am completing my second MS in Complementary Alternative Medicine. I am a true lifelong learner and a firm believer, that higher education is an investment in oneself. In addition to my educational background, I have over 15 years of writing experience, 20 years of clinical practice/research and write medically related works only. While much of my hands on experiences has been in Trauma, Emergency Room and Burn Nursing, I am familiar with a wide variety of topics in medicine and science. I offer a full range of medical writing services and look forward to helping you complete your projects.
    vsuc_fltilesrefresh_TrophyIcon Biotechnology Regulatory Affairs
    Scientific Writing
    Academic Writing
    Qualitative Research
    Clinical Systems CTMS
    Academic Editing
    Medical Law
    Medical Report
    Quantitative Research
    Academic Research
    Medical Editing
    Content Writing
    Clinical Trial Management System
    Project Management
    Copy Editing
  • $10 hourly
    🎖️ Top-Rated Plus Freelancer (Top 3%) 🎖️ 95% - Job Success 🎖️ Availability & Working Hours: (40+ hrs/week) I am fully expert in Data Entry, Data Mining, Internet Research, Web Scraping, Lead Generation, B2B Lead Generation, Linked-in Lead Generation & Social Media Lead Generation with 4+ years of experience in the freelancing field. I am dedicated to my job, keen on details, and can work with less supervision. I'm a very hard and fast worker, reliable, detail-oriented, and self-motivated, take every job seriously, and help you achieve the target you aim for your business/company. ★★★My Specialties★★★ ★ Lead Generation ★ B2B Lead Generation ★ Market Research ★ LinkedIn Researcher ★ Contact List Building ★ Database Building ★ Email List Generation ★ Valid and Verified Email Addresses ★ Lead List Building ★ Prospect List Building ★ LinkedIn Prospecting ★ Data Entry ★ Data Mining and Extraction ★ Data Extraction & Scrape ★ Data Collection ★ Microsoft Excel ★ Spread Sheets ★ Facebook links Discovery ★ Linked in links Discovery For finding a different type of Persons and Businesses Mostly I'll use these websites: ★ Linked in ★ Google Maps ★ Crunchbase ★ Bloomberg ★ Yelp.com ★ Yell.com ★ Yellow Pages ★ Manta.com ★ Euro Pages ★ Clutch.co ★ BBB ★ Thomas.net I'll use these tools for extracting emails from LinkedIn and websites: ★Hunter.io ★Rapportive ★Rocket Reach ★Kendo ★Prophet ★Nymeria ★Zoominfo ★Contactout ★Clearbit ★Leads Gibbon If you have any questions feel free to ask me. Looking forward to working with you. Thank You!
    vsuc_fltilesrefresh_TrophyIcon Biotechnology Regulatory Affairs
    IT Recruiting
    Recruiting
    LinkedIn Development
    Online Research
    LinkedIn Recruiting
    B2C Marketing
    Customer Relationship Management
    Data Mining
    Candidate Evaluation
    Resume Screening
    LinkedIn
    B2B Marketing
    Lead Generation
    Data Entry
    Email Marketing
  • $100 hourly
    Demetris has a unique academic skill-set; He obtained his bachelor and masters degrees from top universities in the UK (UCL, Imperial College London, London School of Economics) and in France (Grenoble Ecole de Management). Following the completion of his studies he joined a multinational financial advisory firm and progressed his career as a Corporate Finance specialist. Throughout his career he has completed numerous projects with focus on Corporate Finance and Venture Capital.
    vsuc_fltilesrefresh_TrophyIcon Biotechnology Regulatory Affairs
    Financial Modeling
    Business Valuation
    Business Planning & Strategy
    Business Plan
    Market Analysis
    Management Consulting
    Biotechnology
    Financial Analysis
    Business Analysis
    Corporate Finance
  • $250 hourly
    **AVAILABLE TO ASSIST WITH MoCRA COSMETIC REGISTRATION & LISTING REQUIREMENTS** ** 510(k) eSTAR EXPERT -- I was part of the pilot program and have already cleared products using the eSTAR format ** For the past 25 years, I have been assisting foreign and domestic firms with creating and executing their strategy for U.S. FDA regulatory compliance. I have a high level of expertise in the areas of drugs, medical devices, foods, and cosmetics. I specialize in working with medical devices. I have assisted more than 1,000 companies, running a firm that is woman- and minority-led. While my capabilities are vast, the services I provide on this platform are expert level and limited to the following: - Fractional Chief Regulatory Officer (CRO) - add me to your team to provide ongoing support for all FDA and Quality System matters, so you can focus generating revenue for your business - Drug label reviews, Drug Establishment Registration, Drug Product Listing (and all related activities) - Medical Device label reviews, Drug Establishment Registration, Drug Product Listing (and all related activities) - Release of detained products - Annual U.S. Agent (drugs/devices) - Cosmetic, device, drug, and supplement label reviews - 510(k) submissions, De Novo Submissions, Presubmission meetings - Food Establishment registration and Prior Notice - Responses to "It Has Come To Our Attention" letters - FDA on-site inspection support - 21 CFR 820 Quality System support (SOP creation, training, and implementation, annual internal audits, etc.) - Ingredient Research Most of my projects are billed on a flat-rate per product, per submission, or per monthly basis. I only do a few hourly projects -- generally those are related to research.
    vsuc_fltilesrefresh_TrophyIcon Biotechnology Regulatory Affairs
    Label Design
    Drug Regulation
    Food & Supplements
    Compliance
    Product Label
    Cosmetic Regulation
    Regulatory Compliance
    Label Compliance
    Medical Device
    Medical Device User Manual
  • $200 hourly
    Specialist biomedical researcher with +15 years of experience in academia focusing on oncology, pharmacology, genetics and psychiatry. Multilingual communicator, adept at presenting to medical and health professionals, while an accomplished medical writer and editor, contributing to over 50 cited publications in peer reviewed journals. 4 yrs as a regulatory consultant for medical device companies. My services include: - Clinical Evaluation Plans and Reports for MDR, class II and III - manuscript writing/editing - grant submissions - scientific website content - scientific presentations
    vsuc_fltilesrefresh_TrophyIcon Biotechnology Regulatory Affairs
    Medical Translation
    Science
    Molecular Biology
    Bioinformatics
    Science Tutoring
    Biostatistics
    Medical Editing
    Manuscript
    Scientific Research
  • $100 hourly
    Working in many different industries and various departments has allowed me to bring a unique approach to projects and consider many items that others would not think about! Serving clients in the USA (several states), Canada, Brazil, England, and Switzerland by performing value-adding functions such as: • Identifying areas of risk (and potential fraud) and opportunities to improve business processes • Finding cost savings and increasing efficiencies • Creating and enhancing internal controls within policies & procedures to safeguard assets, data, and integrity of processes • Disaster Recovery and Business Continuity plans • Gap analysis of current practices to various requirements (regulatory, company/industry standards, best practices, etc.) • Guiding new and expanding businesses • Developing and maintaining effective client relationships Certifications: CIA: Certified Internal Auditor – Institute of Internal Auditors (IIA) CISA: Certified Information System Auditor – Information Systems Audit and Control Association (ISACA) CFE: Certified Fraud Examiner (CFE) – Association of Certified Fraud Examiners (ACFE) CRMA: Certification in Risk Management Assurance – Institute of Internal Auditors (IIA) CCSA: Certification in Control Self-Assessment – Institute of Internal Auditors (IIA)
    vsuc_fltilesrefresh_TrophyIcon Biotechnology Regulatory Affairs
    Company Policy
    Regulatory Compliance
    Project Risk Management
    Gap Analysis
    Business Consulting
    Fraud Detection
    Internal Auditing
    IT Compliance Audit
    Information Security Consultation
    Sarbanes-Oxley Act
    Internal Control
    Compliance
  • $55 hourly
    I am a native English speaker with excellent writing skills and a strong background in the life sciences, including a PhD in Biomedical Sciences (neuroscience focus) and 15+ years of research experience. I have a long history of successful collaborations with clients in the biotech, pharma, and healthcare industries. I have authored 200+ articles for various science and health-related websites and have experience in the writing and editing of manuscripts and dissertations (with an understanding of the entire publication process and the importance of fast turnaround times). I am also proficient in the planning and development of a variety of scientific/medical documents that include slide decks, scientific posters, white papers, pamphlets, and brochures. Publications Kaliszewski M, Kennedy A, Blaes S, Shaffer R, Knott AB, Song W, Bossy B, Huang TT, Bossy-Wetzel E. SOD1 Lysine 123 Acetylation in the Adult Central Nervous System. Frontiers in Cellular Neuroscience, 2016 Dec 20;10:287. doi:10.3389/fncel.2016. Kaliszewski, M. The Role of SOD1 Acetylation in Neurodegeneration. The University of Central Florida, UCF Electronic Theses & Dissertations, 2016. Kaliszewski M, Knott AB, Bossy-Wetzel E. Primary cilia and autophagic dysfunction in Huntington’s disease. Cell Death & Differentiation, 2015. 22(9):1413-1424 Bossy, K, Kaliszewski, M, Kincaid, B, Yin, HY, Chen, J, Song, W, Bossy, B, Verdin, E, Bossy-Wetzel E. Sirtuin3 Regulates Mitochondrial Fusion by Reversible Optic Atrophy1 Deacetylation. Invest. Ophthalmol. Vis. Sci., 2014. 55:2399–2399. Banaudha K, Kaliszewski M, Korolnek T, Florea L, Yeung ML, Jeang KT, Kumar A. MicroRNA silencing of tumor suppressor DLC-1 promotes efficient hepatitis C virus replication in primary human hepatocytes. Hepatology, 2011 Jan;53(1):53-61. Kaliszewski, M. The epigenetic role of microRNAs in the regulation of host tumor suppressor genes induced by hepatitis C viral infection in primary human hepatocytes. The George Washington University, ProQuest Dissertations Publishing, 2010. Trapé-Cardoso M, Bracker A, Grey M, Kaliszewski M, Oncken C, Ohannessian C et al. Shade Tobacco and Green Tobacco Sickness in Connecticut. J Occup Environ Med. 2003 Jun;45(6):656-61
    vsuc_fltilesrefresh_TrophyIcon Biotechnology Regulatory Affairs
    Manuscript
    APA Formatting
    Scientific Research
    Academic Editing
    Blog Writing
    Content Writing
    Scientific Writing
    Human Science
    Biotechnology
  • $10 hourly
    Experienced in Preparation of Scientific Planner as per customer need Handling and Quality Check of large database for structured data, searching of web based data Backend Data compilation and live entry of data for company’s product Familiarity and experience in using coding languages(Python) Excellent excel skills, mail merging Good knowledge of regulatory documentation and drug development process. Knowledge of regulatory guidelines for New Drugs approval, clinical trials, Registration, Import license of New Drug and Subsequent Drug, Test license in the country as per provisions of Drugs & Cosmetics Act & Rules. Knowledge of Schedule Y, ICH and Indian GCP guidelines for conduct of clinical studies in country. Understanding of the drug development and clinical process. Good computer skills and skilled with client templates; Good knowledge of document management systems and other relevant applications (e.g. Excel, Outlook) • Review of regulatory documents such as those associated with filings and dossiers, pertaining to clinical trials, market authorization, new drugs approval, clinical trial approval, BA/BE study approval this included study of investigation of clinical study reports, clinical study protocol, annual reports, investigator brochures, case record form, stability study data and other relevant manuscripts. • Handling of SAE (Serious Adverse Event) Reports and writing medically relevant safety narrative of case and checking the completeness of case, along with verification of the information/documents submitted by sponsor, investigator and ethics committee for the relatedness / non-relatedness of SAE that occurred during conduct of clinical trial, calculation of compensation amount to be paid to legal heir of subject/ subject as per provisions of Drugs and Cosmetics Rules 1940 along with verification of the information/ documents submitted by Sponsor, Investigator and Ethics Committee to make sure that the submission of data was done according to Schedule Y of D&C act, 1945 and identification of protocol deviations, misconducts during the clinical trial and Calculation of the compensation to the subject/ legal heir/ nominee as per 122 DAB and Appendix-XII of Schedule Y to Drugs & Cosmetics rules 1945, in case of SAE related to the Investigational product/ clinical trial. Scrutiny of applications pertaining to Import and Registration as per provisions of Drugs and Cosmetics Act, 1940 and Rules there under Evaluation of Bioequivalence and Clinical Trial Protocol and their reports, summarization of clinical data. Scrutiny of applications pertaining to Additional Indications, Additional Strengths, New Dosage Form, Package Insert Update, Ethics Committee Registration, PSURs, Post Marketing Surveillance Reports Work on knowledge output on Sector – reports published by FICCI, industry representations to government stakeholders like NPPA, Department of Pharmaceuticals, GoI, MoHFW presentations on thematic areas Develop concept notes/ proposals for projects, thematic discussion papers Develop and maintain documents templates and high-quality systems for tracking regulatory submissions, reports for policy briefs and representations, work on stakeholder consultations and meetings for policy discussions, provide policy feedback to relevant government in a structured manner. Execute outreach events and delegations, work with team to develop concept notes, budgets, and agenda for events Participate in various task force activities of Pharma committee and project meetings related to area(s) of responsibility. Implements all activities related to the preparation of e.g. abstracts, posters/ presentations, manuscripts or to the preparation and compilation of data and information into a single comprehensive package for pharma sector. Provide scientific expertise to sectoral team in the development of new business proposals like Proposal under Pharmaceutical Product Development Scheme to Department of Pharmaceuticals, MoCF, GoI Perform literature searches/reviews and research current guidelines as necessary to gather background information and training for development of documents for Pharma sector specific issues.
    vsuc_fltilesrefresh_TrophyIcon Biotechnology Regulatory Affairs
    Drug Regulation
    Artificial Intelligence
    Medical Device
    Biotechnology Regulation
    eClinicalWorks
    Risk Assessment
    Secondary Research
    Procedure Development
    Pharmacovigilance
  • $35 hourly
    My goal is to make documents organized and easy to understand. I have pharmacy background and have worked in the pharmaceutical and medical device industry for more than 9 years in regulatory affairs field. I work in the region of Asia, USA and Switzerland. I have experience writing technical documents and familiar with ICH structure. I am proactive, organized and commit to the deadline.
    vsuc_fltilesrefresh_TrophyIcon Biotechnology Regulatory Affairs
    Regulatory Compliance
    Medical Device
    Medical Translation
    Drug Regulation
    English to Mandarin Chinese Translation
    Chinese to English Translation
    Mandarin Chinese to English Translation
    Biotechnology Regulation
    Mobile App Testing
    Pharmaceutical Industry
    English to Chinese Translation
    Mandarin Dialect
  • $90 hourly
    Are you navigating the complexities of regulatory compliance for health products, cosmetics, medical devices, or food in North America? With over 23 years of hands-on experience and in-depth knowledge, I am here to assist you with all your regulatory needs. What I Offer: 🔹 US Agent Services I provide comprehensive representation for foreign manufacturers, ensuring all FDA and Health Canada requirements are met. 🔹 Label Compliance Whether you need assistance with FDA or Health Canada labeling standards, I will ensure your products meet all regulatory requirements. 🔹 Cosmetic Notification (Health Canada) & MOCRA (US FDA) I facilitate smooth and compliant registrations, ensuring timely approvals and reducing delays. 🔹 Medical Device Submissions (Health Canada) & 510(k) Submissions (US FDA) From premarket notification to licensing, I guide you through the complex regulatory pathways for your medical devices. 🔹 Food Establishment Registration (US and Canada) I manage the entire registration process for food establishments, ensuring compliance with US FDA and Health Canada. 🔹 DIN & NHP Submissions (Health Canada) I have extensive experience preparing and submitting Drug Identification Numbers (DINs) and Natural Health Product (NHP) applications. 🔹 Site Licensing & GMP Certification (Health Canada) I handle site license applications and provide GMP certification support for manufacturers, ensuring they meet all Health Canada standards. 🔹 SOP Review & Writing I review and draft Standard Operating Procedures (SOPs) tailored to your operational needs, ensuring regulatory compliance and efficiency. 🔹 MDSAP & ISO 13485:2016 Certification I assist companies in obtaining MDSAP and ISO 13485:2016 certifications, ensuring their medical devices meet international quality standards. 🔹 HACCP/Food Safety Plans & PCP Plans I develop and implement effective Hazard Analysis Critical Control Points (HACCP) and Preventive Control Plans (PCP) for food safety compliance. Urgent Compliance Needs? I specialize in handling urgent compliance matters, helping you avoid penalties and regulatory delays. Why Work With Me? With a BSc in Pharmacy, an MBA, and being a Certified Regulatory Affairs Professional (RAP), I have the knowledge and experience to navigate the strict regulatory environments of both the U.S. and Canada. My services ensure that your products meet all the necessary requirements to enter and remain in the market successfully. Let’s Get Started! Contact me today to discuss how I can help streamline your regulatory processes and get your products to market faster.
    vsuc_fltilesrefresh_TrophyIcon Biotechnology Regulatory Affairs
    Consumer Goods
    Biotechnology
    Regulatory Compliance
    Label Compliance
    Compliance
    Document Review
    Chemistry
    Drug Regulation
    Article Submission
    Regulatory Intelligence
    Cosmetics
    Technical Documentation
    English
    Proposal Writing
    Retail & Consumer Goods
  • $63 hourly
    Dr. Mohammad Naiem Manager of the Local Pharmaceutical Industry Development Unit at the Egyptian Drug Authority. Mohammad Naiem is a dedicated professional with over 8 years of experience in the pharmaceutical industry. As the Manager of the Local Pharmaceutical Industry Development Unit at the Egyptian Drug Authority, Mohammad is passionate about supporting and enhancing the local pharmaceutical sector. He is responsible for developing and implementing policies and strategies to ensure the quality, safety, and efficacy of pharmaceutical products, fostering innovation and competitiveness within the industry. Mohammad has also played a crucial role in mentoring and 
training other auditors and industry professionals on advanced GMP techniques 
and best practices, He also participate in the industry training and awareness
 through local, and international events. Throughout his career, Mohammad has led and conducted comprehensive audits of pharmaceutical facilities and processes, ensuring compliance with international standards such as WHO, FDA, and EMA. His efforts aiming for significantly reduced non-conformity rates through the application of process improvement methodologies like Lean and Six Sigma, and data analysis. Mohammad holds a Professional Diploma in Pharmaceutical Good Manufacturing Practice (GMP) from the Arab Academy for Science, Technology and Maritime Transport, and a Bachelor’s degree in Pharmaceutical Sciences from Al-Azhar University. He has also obtained certifications in project management, operational excellence, business process improvement, and productivity skills. Recognized as a LinkedIn Top Voice, for his contribution of collaborative articles on Good Manufacturing Practice, Quality Systems, and Risk Management. I look forward to hearing from you! Mohammad Naiem
    vsuc_fltilesrefresh_TrophyIcon Biotechnology Regulatory Affairs
    Drug Regulation
    Scientific Writing
    Biotechnology Regulation
    Quality Inspection
    Regulatory Compliance
    Synthetic Chemistry
    Medical Device
    Academic Research
    Arabic
    Document Review
    Project Management Professional
    Quality Assurance
    Six Sigma
    Good Manufacturing Practice
    Pharmaceutical Industry
  • $125 hourly
    Greetings! I’m Karim Sultan, a multilingual corporate legal professional with 8 years of international experience specializing in contract drafting, terms and conditions, privacy policies, and other documentation drafting. Fluent in English, Arabic, and Bosnian, I provide top-tier legal services and support on a global scale. With a Bachelor’s degree in International Law and experience as a legal associate at esteemed international law firms, I have refined my skills in corporate legal writing and attention to detail. My expertise includes creating robust, compliant, and tailored legal documentation that aligns with client objectives while mitigating risks. Passionate about delivering exceptional results with professionalism and prompt communication, I am dedicated to meeting your unique requirements. Whether you need meticulously crafted contracts, comprehensive policies, or strategic legal consultancy, I am here to help you achieve success. Let’s collaborate to transform your legal needs into impactful solutions and ensure your success with accuracy and compliance. Reach out, and let’s embark on a journey of excellence together! Disclaimer: Important Notice I am not a licensed attorney and do not provide legal advice or engage in the practice of law. The services I offer on this platform are strictly limited to legal document drafting, contract preparation, and general legal consultancy based on my international experience. These services are provided as general assistance and are not tailored to specific jurisdictional requirements. No attorney-client relationship is established through the use of my services, and all documents prepared should be reviewed and approved by a licensed attorney in the relevant jurisdiction to ensure compliance with applicable laws and regulations. Clients are solely responsible for ensuring the accuracy, legality, and enforceability of any documents drafted. By using my services, you acknowledge and agree to these terms.
    vsuc_fltilesrefresh_TrophyIcon Biotechnology Regulatory Affairs
    Employment Law
    Law
    Corporate Law
    Service Level Agreement
    Rental Agreement
    Partnership Agreement
    Non-Disclosure Agreement
    Legal Agreement
    Contract Drafting
    Contract
    Contract Law
    Terms & Conditions
    Privacy Policy
    Legal
  • $60 hourly
    I am a certified six sigma green belt professional and the co-founder of BirdView Software Factory. I have worked on short-term and long-term technical projects throughout my academic and professional career. I’ve taken projects from planning phase to execution of a full development cycle within a constraint given time. I have the ability to conduct extensive research on any given topic, identify business needs, draft a statement of work, conduct a design of experiment, analyze data, and provide results. I have performed project management activities to plan, schedule, track and execute on software products. I have experience using tools such as Slack, uber-conference, zoom, monday.com, Dropbox to facilitate team communication and remote collaboration.
    vsuc_fltilesrefresh_TrophyIcon Biotechnology Regulatory Affairs
    Salesforce CRM
    English to French Translation
    French
    French to English Translation
    Six Sigma
    Agile Project Management
    Microsoft Office
  • $90 hourly
    Over 8 years experience in Regulatory Affairs, V&V and technical submissions for a range of medical devices, including orthopaedics, active implantable and novel, high-risk electromechanical systems. Responsible for authoring several 510(k) submissions for the FDA, including all relevant attachments and reports (clinical evaluations, FMEA risk management files, biocompatibilty reporting, process validations, labeling and packaging etc). Similarly, have authored several technical files and design dossiers for CE marking of Class IIa, IIb and Class III devices. Handled all subsequent follow-ups and questions from Notified Bodies, including on-site audits from both the FDA and BSI. Participated in pres-sub activities with the FDA for novel high-risk implants in the design phase, to establish regulatory pathway to First In-Human trials and subsequent PMA. Achieved and maintained registration of products in a range of jurisdictions including EU, US, Canada, Australia, Israel, Chile and Japan. Familiar with the application of a range of standards including ISO 13485, ISO 14971, IEC 60601, FDA 21 CFR Part 820, as well as upcoming changes in the new EU MDR. Well versed in the development and lodgement of Regulatory Files, and can complete activities such as literature searches, clinical evaluations ,predicate device comparisons, development of SOP's and other QMS documentation, as well as validations for processes such as sterilization (gamma and EtO), packaging, and Human Factors Engineering studies. I look forward to working with you!
    vsuc_fltilesrefresh_TrophyIcon Biotechnology Regulatory Affairs
    Drug Regulation
    Medical Device
    Technical Writing
    Regulatory Compliance
    Biotechnology Regulation
    Quality Control
  • $20 hourly
    Driving Business Growth through Digital Marketing, SEO, and Conversion Optimization ⛔ Don't let the day-to-day grind of running a business hold you back from reaching your full potential. 🎯 Let's talk! Why Partner with Me? 👇 Hi! I'm Flora! Your Jill-of-all-trades Tech Virtual Assistant! I HAVE WORN A LOT OF HATS and I LOVE IT. 👑 Wordpress builders: Figma | Elementor | Beaver Builder | Divi Builder | Thrive Architect | WPBakery Builder | WP Page Builder | Gutenberg | Visual Composer | Bricks 👑 Photo Editing Software Canva | Photoshop | Illustrator 👑 Website Amazon | Shopify | Wordpress | Squarespace 👑 Project management Trello | Asana | Basecamp | Zoho | Airtable | Pipedrive | Plutio 👑 SEO tools Semrush | Google Console | Yoast | Rankmath 👑 Email marketing Klaviyo | Mailchimp | Encharge | Active Campaign | Zenler 👑Productivity tools Microsoft tools | Zoom | Google Suite tools 👑Communication tools Slack | Lastpass | Whatsapp | Telegram 📩 Schedule a call with me and let's discuss how I can take that burden off of your shoulders so you can focus on more important things and prime goals of your business or life. Best, Flora
    vsuc_fltilesrefresh_TrophyIcon Biotechnology Regulatory Affairs
    SEO Localization
    SEO Competitor Analysis
    SEO-Based Website
    SEO Audit
    Content Management
    Graphic Design
    Website Builders & CMS Consultation
    Digital Marketing
    SEMrush
    Yoast SEO
    Elementor
    Squarespace
    Shopify
    WordPress
    Conversion Rate Optimization
  • $25 hourly
    Scientific areas of expertise: epigenetics and aging Scientific/Academic skills: • Drug Discovery • Genetics • Cancer Biology • Immunology • Biochemistry • Molecular Biology • Microbiology • Pharmacology Specializations/online courses: • Immunology (Specialization) • Biostatistics (Specialization) • Astrobiology • Behavioral Genetics • Personalized Medicine Content Writing Skills: • Content Writing • Editing & Proofreading • Team Management • Blog Writing • KPI Analysis • Microsoft Office Suite • Client Relationship Management • Basic Keyword Optimization I am a seasoned molecular biologist with over 2 years of research experience. While my area of expertise is epigeneitcs & aging, I have a profound knowledge of genetics, cancer biology, immunology, biochemistry, metabolism, molecular biology, microbiology, and pharmacology. Moreover, I hold several different certificates in immunology (specialization), biostatistics (specialization), behavioral genetics, astrobiology, and personalized medicine. In my free time, I help businesses grow through data-driven content writing or vivid creative writing. I have experience with content writing, academic writing, editing & proofreading, team management, client relationship management, and basic SEO optimization/best practices. Among other things, I have helped a start-up grow from 400 to over 3,000 organic followers over a period of 7 months. I like to put these skills to use and mix them up with my love for science. That's why I prefer to work with science communication firms. It's really fun to get people excited about science; making science more inclusive and accessible is something I am really passionate about. I am also a freelance software quality tester with over a year of experience in software quality assurance. I have been offering manual testing for UI, UX, and functionality, along with plausible suggestions to some of the biggest names in the industry for years now. I can provide an in-depth analysis in the form of high-quality bug reports; moreover, I also execute scripted test cases with the highest accuracy, should these testing scenarios be provided to me.
    vsuc_fltilesrefresh_TrophyIcon Biotechnology Regulatory Affairs
    Research Papers
    Scientific Writing
    Essay Writing
    Molecular Biology
    Bioinformatics
    Technical Writing
    Cellular Biology
    Biochemistry
    Content Writing
    Biology
    Academic Writing
    Biology Consultation
    Biotechnology
    Biostatistics
  • $55 hourly
    ✅ 𝐌𝐈𝐓 𝐂𝐞𝐫𝐭𝐢𝐟𝐢𝐞𝐝 𝐄𝐧𝐠𝐢𝐧𝐞𝐞𝐫 ✅ 𝐆𝐨𝐨𝐠𝐥𝐞 𝐂𝐥𝐨𝐮𝐝 𝐂𝐞𝐫𝐭𝐢𝐟𝐢𝐞𝐝 𝐂𝐥𝐨𝐮𝐝 𝐀𝐫𝐜𝐡𝐢𝐭𝐞𝐜𝐭 ✅ 𝐀𝐰𝐬 𝐂𝐞𝐫𝐭𝐢𝐟𝐢𝐞𝐝 𝐒𝐨𝐥𝐮𝐭𝐢𝐨𝐧𝐬 𝐀𝐫𝐜𝐡𝐢𝐭𝐞𝐜𝐭 (𝐈𝐧 𝐩𝐫𝐨𝐠𝐫𝐞𝐬𝐬) ✅ 𝐆𝐨𝐨𝐠𝐥𝐞 𝐂𝐥𝐨𝐮𝐝 𝐂𝐞𝐫𝐭𝐢𝐟𝐢𝐞𝐝 𝐒𝐞𝐜𝐮𝐫𝐢𝐭𝐲 𝐄𝐧𝐠𝐢𝐧𝐞𝐞𝐫 ✅ 𝐆𝐨𝐨𝐠𝐥𝐞 𝐂𝐥𝐨𝐮𝐝 𝐂𝐞𝐫𝐭𝐢𝐟𝐢𝐞𝐝 𝐃𝐚𝐭𝐚 𝐄𝐧𝐠𝐢𝐧𝐞𝐞𝐫 I am a results-driven Cloud Engineer with a focus on building, optimizing, and securing cloud solutions on Google Cloud Platform (GCP) and Amazon Web Services (AWS). With certifications across both platforms and MIT certification, I offer deep technical expertise in cloud architecture, infrastructure automation, and scalable solutions that empower businesses to thrive in the digital age. 𝙈𝙮 𝙀𝙭𝙥𝙚𝙧𝙩𝙞𝙨𝙚: 𝗖𝗹𝗼𝘂𝗱 𝗔𝗿𝗰𝗵𝗶𝘁𝗲𝗰𝘁𝘂𝗿𝗲 𝗗𝗲𝘀𝗶𝗴𝗻 𝗮𝗻𝗱 𝗜𝗺𝗽𝗹𝗲𝗺𝗲𝗻𝘁𝗮𝘁𝗶𝗼𝗻 🔸 Designing cloud-native architectures that ensure high availability, fault tolerance, and scalability across GCP and AWS. 🔸 Expertise in multi-cloud strategies, ensuring seamless interoperability between GCP and AWS infrastructures. 🔸 Developing solutions that minimize operational costs while optimizing performance. 𝐈𝐧𝐟𝐫𝐚𝐬𝐭𝐫𝐮𝐜𝐭𝐮𝐫𝐞 𝐚𝐬 𝐂𝐨𝐝𝐞 🔸 Automating infrastructure provisioning with Terraform, CloudFormation, and Ansible for consistent and efficient deployments. 🔸 Implementing infrastructure as code (IaC) principles to create reusable, version-controlled cloud resources, reducing manual intervention and enhancing security. 𝐂𝐥𝐨𝐮𝐝 𝐒𝐞𝐜𝐮𝐫𝐢𝐭𝐲 𝐁𝐞𝐬𝐭 𝐏𝐫𝐚𝐜𝐭𝐢𝐜𝐞𝐬 🔸 Implementing robust security controls, including IAM policies, encryption, and security monitoring, across GCP and AWS environments. 🔸 Expertise in AWS Security Hub and GCP Security Command Center to provide proactive threat detection and response mechanisms. 🔸 Designing secure, scalable networks with virtual private cloud (VPC) configurations, firewalls, and VPNs. 𝐊𝐮𝐛𝐞𝐫𝐧𝐞𝐭𝐞𝐬 𝐚𝐧𝐝 𝐂𝐨𝐧𝐭𝐚𝐢𝐧𝐞𝐫 𝐎𝐫𝐜𝐡𝐞𝐬𝐭𝐫𝐚𝐭𝐢𝐨𝐧 🔸 Orchestrating and managing containerized applications using Google Kubernetes Engine (GKE) and AWS Elastic Kubernetes Service (EKS). 🔸 Utilizing Helm for seamless application deployment and updates while ensuring the security of containerized environments. 🔸 Managing CI/CD pipelines using Jenkins, GitLab CI, and GitHub Actions to automate build and deployment processes for containerized services. 𝐂𝐥𝐨𝐮𝐝 𝐌𝐢𝐠𝐫𝐚𝐭𝐢𝐨𝐧 𝐒𝐭𝐫𝐚𝐭𝐞𝐠𝐲 🔸 Expertise in migrating on-premises infrastructures to GCP and AWS with zero downtime. 🔸 Ensuring data integrity and continuity through meticulous migration strategies that prioritize business operations and workload performance. 🔸 Post-migration fine-tuning to enhance performance and cost efficiency on the cloud. 𝗖𝗹𝗼𝘂𝗱 𝗖𝗼𝘀𝘁 𝗢𝗽𝘁𝗶𝗺𝗶𝘇𝗮𝘁𝗶𝗼𝗻 🔸 Analyzing cloud resource usage to identify cost-saving opportunities without sacrificing performance. 🔸 Implementing autoscaling, reserved instances, and serverless computing (AWS Lambda, GCP Cloud Functions) to achieve cost-efficient solutions. 𝗗𝗶𝘀𝗮𝘀𝘁𝗲𝗿 𝗥𝗲𝗰𝗼𝘃𝗲𝗿𝘆 𝗮𝗻𝗱 𝗕𝘂𝘀𝗶𝗻𝗲𝘀𝘀 𝗖𝗼𝗻𝘁𝗶𝗻𝘂𝗶𝘁𝘆 🔸 Designing disaster recovery plans to ensure your business remains resilient in the event of system failures or outages. 🔸 Architecting backup and recovery strategies using AWS Backup and GCP's Backup and DR service for data protection. 𝗪𝗵𝘆 𝗖𝗵𝗼𝗼𝘀𝗲 𝗠𝗲 🔸 GCP & AWS Expertise: Extensive hands-on experience with both platforms, allowing me to provide comprehensive solutions tailored to your needs. 🔸 MIT Certified Engineer: A solid foundation in technical problem-solving and cutting-edge cloud innovations. 🔸 Proven Results: Track record of delivering cloud projects that enhance efficiency, reduce costs, and ensure robust security. 🔸 Client-Centric Approach: I prioritize clear communication, understanding your goals, and delivering solutions that exceed expectations. Let's discuss how I can bring my cloud engineering expertise to elevate your projects. Whether it's designing a scalable architecture, migrating your systems to the cloud, or optimizing your cloud environment, I'm here to make it happen.
    vsuc_fltilesrefresh_TrophyIcon Biotechnology Regulatory Affairs
    Cloud Computing
    Network Security
    Cloud Migration
    Docker
    Containerization
    Kubernetes
    Cloud Engineering
    Bash
    Network Design
    DevOps Engineering
    Terraform
    Data Warehousing & ETL Software
    Google Cloud Platform
    Python
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