Hire the best Drug Regulatory Affairs professionals

Check out Drug Regulatory Affairs professionals with the skills you need for your next job.
  • $160 hourly
    I am a Regulatory and Quality Consultant with expansive regulatory and quality experience with medical devices, OTC drugs, supplements, cosmetic products and surface cleaners. Over the last 20 years I've held various senior and executive level management positions within FDA and EPA governed companies. I started my career as an Environmental Analytical Chemist and I held my most recent position for 9 years as QA/RA Director for a Henry Schein specialty company, Ortho Technology, a worldwide distributor of orthodontic medical devices. I would love to help you get your new product to the market, as I have experience in regulatory requirements in over 50 countries! Some of my other specialties include technical writing to include SOPs (standard operating procedures), white papers, product submissions/dossiers, Organizational SOP writing (for any type of business), Overall Quality Management Systems that comply with ISO standards and various worldwide regulatory entities. I am well versed with FDA compliant advertising and can assist you with your device and drug label development and/or editing to ensure you are compliant to your jurisdiction. All of these skills require research, so yes, I am really good at that too! My forte and favorite thing is label compliance review! I can review your device, OTC drug, supplement, food, and cosmetic labels for compliance to US FDA, EU Directives, Health Canada and more! Check out my linked in profile for links to a few of the regulatory articles I have written recently. You can also search my name on the FDA website to find 510(k) evidence and other regulatory compliant reports that I have written and submitted.
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    Product Label
    Legal
    Drug Regulation
    Cosmetics
    Food & Supplements
    Regulatory Compliance
    Label Compliance
    Medical Device
    Compliance
    Quality Assurance
    Legal Consulting
    Technical Writing
  • $75 hourly
    - US Agent services - Label Compliance - Cosmetic Notification Health Canada - VCRP US FDA - Medical Devices Submission Health Canada - 510 (k) submission - Food Establishment Registration US and Canada - Urgent Compliance needs - OTC Registration FDA - DIN submission Health Canada - NHP Submission Health Canada - Site License submission Health Canada - GMP certification services - Review of SOPs and Writing SOPs - MDSAP certification - ISO 13485:2016 certification - HACCP/Food Safety Plan - PCP Plan, and more
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    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
  • $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.
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    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
  • $22 hourly
    Thai native speaker with fluent English. Full-time translator since 2012. Various fields of projects done especially through Upwork e.g. subtitling, localization, general translation, medical translation, Thai boxing-related translation, legal translation, etc. I am also a voice talent!
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    Documentation
    Contract Translation
    Legal Translation
    Official Documents Translation
    Email Communication
    Website Translation
    Thai
    Medical Translation
    Mobile App Localization
    English to Thai Translation
    Thai to English Translation
  • $175 hourly
    Highly motivated Product Formulation Expert and Regulatory Affairs Expert in the following fields: Medical Devices ,Pharmaceuticals ,Dietary Supplement DEMONSTRATED EXPERTISE IN formulating : - Dietary SUpplements - Hydrogen Water - Gummy Products - Effervescent Tablets With market expertise in United States ,Canada ,Australia ( TGA) ,New Zealand United Kingdom ,European Union and UAE PRESCRIPTION MEDICINES Demonstrated Expertise in the following fields in a contractor capacity for over 10 years as a freelancer specializing in : - Classification + Registration of Generic , OTC , and Prescriptions ,CTD Module Preparation ,Dossier Review Analysis ,Pre Submission Meetings and Liaison ,GMP Clearance and Licensing ,Post-Market Surveillance & Vigilance ,Advertising and Marketing Compliance Assessment ,Pharmacovigilance DIEATRY SUPPLEMENTS Demonstrated Expertise in the following fields in a contractor capacity for over 10 years as a freelancer - Consulting services in the areas of Dietary Supplements and Food Supplements including GMP, Market Registrations, TGA product registrations, FDA submissions, Formulation Compliance , Label Compliance Quality Assurance , Quality Control and Manufacturing Product Formulation and Regulatory Affairs With market expertise in United States , Canada ( Health Canada),Australia ( TGA) ,New Zealand ( Medsafe),United Kingdom ( MHRA),European Union ( Various Countries),UAE,Ireland RELEVANT QUALIFICTIONS : Regulations of Dietary Supplements and NHP's (FDA/Canada) Regulatory Affairs Certificate : Pharmaceuticals ( US , Canada , EU ) Bachelor of Health Science Complementary Medicine Advanced Diploma Nutritional Medicine Certificate of Pediatric Nutrition. DETAILING MY KEY SERVICES IN : Regulatory Affairs - Cosmetic, Pharmaceutical and Food Supplements and Medical Devices Product Development of tablets , powders, capsules. Cosmetic Formulations - pressed powders , oils , creams Product Registrations ( Both International and Australia) Quality Assurance and GMP Ingredient Sourcing Labelling / Packaging Compliance With over 10 years experience I can help you develop your idea into a full cycle product on the shelf , contact me today for a quote.
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    Legal Consulting
    Regulatory Intelligence
    Medical Device
    Food & Supplements
    Cosmetic Regulation
    Regulatory Compliance
    Product Formulation
    Drug Regulation
    Product Development
    Retail & Consumer Goods
  • $25 hourly
    I have a Doctorate of Pharmacy (PharmD.) from Al Azhar University and work experience in the medical field since 2014. My work experience involves: 👉Working with an American biotech company (VCENNA) on a new drug formula 👉Working with an American research institute (Alamgir Research Inc) on a project related to Covid-19 👉Working as the official pharmacologist and writer for a trusted AMERICAN brand (AMANDEAN) that sells supplements 👉.Working as the lead writer for a health platform (3afiyah) (many of my blogs ranked very good on Google) 👉Working with academic researchers on different research projects 👉Complete research projects for independent researchers. Please have a look at the following testimonials from a client after completing a job related to “Medical literature reviews”: “ Randa provided the work on time. She performed an impressive review of the literature and delivered a fully written review on the topic that was BEYOND expectations. She is fluent in English with above-average writing skills. The review was well-organized with all needed references properly cited.” My services related to my background include but are not limited to: ✅Academic medical research and writing.📖 ✅Medical literature research and reviews 📚. ✅Writing medical case reports 🔬. ✅ Writing, Editing, and Fact-checking medical articles and blogs.❌Plagrism 💹SEO optimized. ✅ Creating PowerPoint presentations both for learning purposes 📖.and conferences🔖 As a freelancer: ✅I take my work and client's instructions with the seriousness it deserves. ✅I understand the importance of constant communication with the client ✅I respect deadlines The following testimonial was from a previous client that required the project to be completed within a very tight deadline: “Thorough research and effort into a rather broad topic. More prompt feedback with ongoing progress appreciated to gauge project status close to deadline. Overall strong work especially with such a tight window and daunting task." 💡As a hard work person, you can be sure that I am a good fit for any job related to my field of expertise 💡Please don’t hesitate to reach out if you find my profile compelling💡
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    Linux System Administration
    Technical Writing
    Regulatory Compliance
    Academic Research
    Drug Regulation
    Academic Writing
    Qualitative Research
    Research Papers
    Article
    Medical Report
    Pharmacology
    Content Writing
    Pharmaceutical Industry
    Pharmaceuticals
  • $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.
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    Label Design
    Drug Regulation
    Food & Supplements
    Compliance
    Product Label
    Cosmetic Regulation
    Regulatory Compliance
    Label Compliance
    Medical Device
    Medical Device User Manual
  • $45 hourly
    I am a Physician Assistant and biomedical research scientist with extensive basic, GLP pre-clinical and clinical research experiences. I successfully received multiple grants, actively contributed to three gene therapy IND submissions, several publications and have two patents to my credit. I have been a medical professional for over 20 years and 18+ years in biomedical and clinical research. As a writer, I have expertise in authoring pre-clinical reports, IND/IDE submissions, academic and corporate grant proposals, patent applications, original manuscripts and more. All my writing experience come from my various academic and industrial positions, so I don't have much freelance credit to display on this platform. Please feel free to reach out to me and I can demonstrate to you the quality of my work.
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    Editing & Proofreading
    Genomics
    Molecular Biology
    Clinical Trial
    Technical Writing
    Report Writing
    Biotechnology Regulation
    Research Proposals
    Drug Regulation
    Technical Editing
    Regulatory Compliance
    Medical Device
    Research Protocols
  • $20 hourly
    Greetings! I am a seasoned medical professional with a wealth of experience in general medicine, specializing in diabetes. With a strong foundation in the pharmaceutical industry, I bring a unique perspective to medical writing. As a dedicated and detail-oriented medical writer, I am passionate about transforming complex medical information into engaging and accessible content. Worked for the last 15 years in the pharmaceutical industry, healthcare, and Digital Marketing. I have immense experience in medical writing and product management (human health, veterinary medicine, biotechnology, vaccines, nutraceuticals/food supplements, medical equipment and devices), writing white papers for healthcare products, writing research papers, conducting clinical trials, creating educational materials, presentations, and graphics development. 🔍 Why Choose Me: 🌐 Versatility: My background in general medicine, diabetes specialization, and pharma industry insights allows me to tackle a wide range of medical writing projects. 🔬 Accuracy: I prioritize accuracy and evidence-based information, ensuring that all content meets the highest standards of medical integrity. 📝 Engaging Content: I believe in making complex medical concepts accessible to a broad audience through clear, concise, and engaging writing. ⭐ I have working experience in more than 15 countries, from central Europe to South Asia. 🏆 Education: M.D. (general medicine), FID (fellowship in diabetes), certificate courses in project management, neurology, and infectious diseases. 📈 Let's Collaborate! Whether you need a medical writer for articles, blog posts, or industry insights, I am here to bring your ideas to life. Let's work together to create impactful and informative content that resonates with your target audience.
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    Food & Supplements
    Pharmaceutical Industry
    Health & Fitness
    Blog Content
    Blog Writing
    Website Content
    Scientific Writing
    Content Writing
    SEO Writing
    Copywriting
    Ebook
    Editing & Proofreading
    Academic Writing
    Article Writing
    Health & Wellness
  • $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
  • $40 hourly
    I have six years of Regulatory affairs experience in Pharma industry. Submitted market authorization application to US-FDA (ANDA), EU and MHRA (Generic hybrid application), and have experience of compliance audit of APIs and excipients manufacturing according to ICH Q7. My experience include leading project from product development to market authorization, Including drafting dossiers (M1, M2 and M3), review, gap analysis to avoid RTR (Refuse to Receipt) and submission to health agency via E-CTD. Pre ANDA communication with FDA including control correspondence, Q1 and Q2 Sameness assessment and threshold analysis consultation can be provided for pre assigned apllication.
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    Research & Development
    Product Development
    Writing
    Regulatory Compliance
    Drug Regulation
  • $150 hourly
    Leadership: Have led a team of statisticians in supporting statistical activities in 2 therapeutic area portfolios and programmers supporting regulatory reporting for over 100 clinical trials Technical: Strong experience in providing lead statistical support for regulatory activities such as FDA Panel meetings, in-person FDA meetings, PMA submissions, FDA study design conference calls, FDA deficiency responses and regulatory report submissions Programming: SAS (10+ years) and experience using R
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    Logistic Regression
    Statistical Computing
    Scientific Research
    Multivariate Statistics
    Linear Regression
    Statistical Programming
    Biostatistics
  • $26 hourly
    Expert in developing ISO 27001 Information Security, Penetration Testing, ISO 9001, ISO 14001, ISO 22000 Food Safety Management System, HACCP Plan, ISO 22716 Cosmetic Good Manufacturing Practices, FDA Guidelines on Cosmetics, OHSAS 18001 (Occupational Health & Safety), ISO 9001: 2008 to ISO 9001: 2015 upgradation, ISO 27001, ISO 13485 Medical Device QMS, 510 (k) Undertake accounting, book keeping outsourcing projects. Currently providing Book Keeping services to companies in the US. Write Standard Operating procedures ( SOP ) and develop Business Process Flow Charts in Visio. Expert Business Manual Writer, Handbook Writer, Academic Writer, also write Blogs, Web Marketing Content, White Papers, News Reports.
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    Business Plan
    Flowchart
    ISO 9001
    ISO 27001
    Market Research
    ISO 9000
    Business Process Modeling
  • $20 hourly
    • More than 10k hours web research experience in a number of areas. • Quick learner, active, flexible and always in a mood for work. • Microsoft Excel, Word, PowerPoint, Google Suite, Trello
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    Lead Generation
    Product Research
    Industry Research
    Article Writing
    Review
    Topic Research
    Microsoft Excel
    Data Entry
    Microsoft Word
    Creative Writing
  • $15 hourly
    Top Highlights - 🌟 Top Rated Plus Freelancer - ⏰ 10,000+ Hours Worked - 💼 100+ Businesses Helped - 📅 4+ Years of Experience As a seasoned Virtual Assistant and Digital Marketing Expert with over four 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. 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.
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    Digital Marketing
    Email Communication
    Project Management
    Amazon Listing
    Amazon FBA
    Amazon Seller Central
    Social Media Content Creation
    Administrative Support
    WordPress e-Commerce
    Social Media Marketing
    Social Media Management
    Amazon Listing Optimization
    Search Engine Optimization
  • $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 Drug Regulatory Affairs
    Manuscript
    APA Formatting
    Scientific Research
    Academic Editing
    Blog Writing
    Content Writing
    Scientific Writing
    Human Science
    Biotechnology
  • $20 hourly
    I'm a Master of Architecture and Engineering. My relevant skills (architectural and non-architectural) include: - AutoCAD; - ArchiCAD; - Sketchup w/ Vray; - Artlantis; - Lumion; - Adobe Photoshop; - Adobe InDesign; - MS Office; - Google Docs; - Google Sheets; - Freehand drawing; - Imaginative and creative thinking skills; - Designing building concepts; - Floorplanning; - 3D rendering; - Essay writing; - Fluency in English, Macedonian, Serbian, Croatian, and a basic understanding of German. I'm a dedicated, dynamic, and proactive person with an excellent work ethic, willing to do any work related to my field or relevant skills.
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    Architectural Rendering
    Architectural Design
    Data Curation
    Data Entry
    UX & UI
    Architecture
    Microsoft Word
    Artlantis 2021
    2D Design
    Autodesk AutoCAD
    SketchUp
    Residential Design
    Adobe Photoshop
    Adobe InDesign
    3D Design
  • $50 hourly
    More than 10 years of experience in Quality Management System, more than 5 years of experience in medical device regulations (CE mark, ISO 13485, ISO 9001, MDSAP, FDA QSR 21 CFR Part 820). Systems: Quality Management System, Medical Device Management System, Regulatory Requirements, Risk Management, CE marking - Technical file requirements. Qualification: Certified external auditor for ISO 13485, ISO 9001 and MDSAP. Standards and Directives: ISO 13485, FDA QSR CFR 21 Part 820, FDA CFR 21 Part 11, ISO 14971, EN 62366, EN 62304, ISO 9001, ISO 19011, EN 60601-1, EN 60601-1-2, MDD (93/42/EEC), MDR Regulation (EU) 2017/745, ISO 27001, ISO 20000-1, ISO 14001, RoHS2 Directive. Auditing: Audit of Quality Management System and Medical Device Management System (Internal and External Audit), Supplier Audit, Technical File Audit according to MDD (93/42/EEC).
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    Project Risk Management
    English
    Software Documentation
    Medical Device
    ISO 9001
  • $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
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    Basecamp
    Xero
    Property Management
    Buildium
    Trello
    Bookkeeping
    Email Marketing
    Ecommerce
    AppFolio
    Google Workspace
    Social Media Marketing
    Intuit QuickBooks
  • $40 hourly
    Welcome to my Upwork profile! With almost 20 years of experience in the Graphic Design industry, I specialize in packaging and books production. Here's why you should consider working with me: 🥇 Top-Rated Upwork Badge recipient for consistent excellence in delivering high-quality work in a fast turnaround. 💯 100% Job Success Score, a testament to my commitment to client satisfaction. My areas of expertise are: - Adaptive design - Artwork production - PrePress - Building DFP, SFP and NFP - Typesetting Financial Reports I approach every project with dedication and a client-oriented mindset ensuring the final result exceeds your expectations. Click on "Invite to job" button above, to start a conversation and discuss your project in detail with no commitment and as an opportunity for us to get to know each other, explore your ideas, and determine how we can collaborate effectively. Let's start!
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    Print Production
    Annual Report
    Drug Regulation
    Desktop Publishing
    Food & Supplements
    Packaging Dieline
    Adobe Photoshop
    Packaging Design
    Label & Packaging Design
    Typesetting
    Graphic Design
    Adobe Illustrator
    Adobe InDesign
    Brochure
  • $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.
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    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
  • $75 hourly
    I am a graduate of Biology major in Microbiology with 17 years of experience in Quality Assurance focused on HACCP, Supplier Accreditation and Quality Management. DATA MANAGEMENT and VISUALIZATION - Creates database in MS Excel and Google Sheet - Manage data and create dashboards DOCUMENT CONTROL, FREELANCE WRITING - Creates procedures, work instruction, and forms that can be used for ISO certifications - Establishes Document Control Program/ System OTHER QUALIFICATIONS AND SKILLS: - Email Management - Slack, Google workspace - Creation of training materials - Performs training of employees (Face to face and Virtual) - Conducts Audit (GMP/HACCP), Performs Supplier Audits I believe in maximizing every minute of the day by effectively prioritizing tasks. I am a reformer, challenger, enthusiast, achiever and investigator based on my last Enneagram test. I empower the team through effective communication, collaboration and encouraging creativity.
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    Writing
    Process Safety
    English
    Business Services
    Financial Audit
    Training Materials
    Content Writing
    Training Plan
    Food & Beverage
    Training & Development
    Regulatory Compliance
    Audition Preparation
    Training Design
  • $34 hourly
    📌𝐓𝐨𝐩 𝐑𝐚𝐭𝐞𝐝 𝐏𝐥𝐮𝐬 (𝐔𝐩𝐰𝐨𝐫𝐤 𝐭𝐨𝐩 𝟑% 𝐓𝐚𝐥𝐞𝐧𝐭) 📌𝟓𝟎𝟎𝟎+ 𝐡𝐨𝐮𝐫𝐬 𝐨𝐧 𝐔𝐩𝐰𝐨𝐫𝐤. With over 10 years' experience in medical and scientific research field, I am the perfect freelancer to complete your tasks. I am reliable, I take my work seriously and I deliver on my promises 110%. ⭐⭐⭐ Summary of skills & abilities ⭐⭐⭐ These are services that I provide: 📚Searching through available databases of, Clinical Trials, biomedical literature (PubMed, The Cochrane Library, Lilacs, Google Scholar) and excerpting medical details of interest. 📚Provision of results in the desired form (Short Summaries, Microsoft Excel file, Google Sheets file, Microsoft PowerPoint file, Google Slides file) 📚 Medical Written Material Annotation: Following Annotation Rules for Enhanced Documentation 📚 Editing & Proofreading, Writing, Transcription, and Translation 📚Unlocking Insights: Medical Records Review and Summarization for Comprehensive Healthcare and Academic Analysis. Transforming Complex Medical Data into Easy-to-Understand Language 📚 Advancing Knowledge: Scientific Research, Medical Research, Medical Reports, and Drug Reports for Groundbreaking Discoveries 📚 Pharmaceutical Research: Ensuring Drug Safety, Pharmacovigilance, and Expert Drug Advice 📚 Unlocking Insights: Clinical Informatics and Data Collection for Enhanced Cosmetic Formulation and Brand Research. 📚 Clinical Trial Research Specialist for Nutraceuticals, dedicated to uncovering the best scientific evidence for health and wellness. 📚 Comprehensive Market Research Analysis of the Medical Field: Key Trends, Growth Opportunities, and Competitive Landscape. 𝐌𝐚𝐬𝐭𝐞𝐫 𝐨𝐟 𝐒𝐜𝐢𝐞𝐧𝐜𝐞 𝐢𝐧 𝐏𝐡𝐚𝐫𝐦𝐚𝐜𝐞𝐮𝐭𝐢𝐜𝐚𝐥 𝐒𝐜𝐢𝐞𝐧𝐜𝐞𝐬 | 𝐃𝐢𝐞𝐭𝐚𝐫𝐲 𝐒𝐮𝐩𝐩𝐥𝐞𝐦𝐞𝐧𝐭𝐬 𝐒𝐩𝐞𝐜𝐢𝐚𝐥𝐢𝐬𝐭 ✓ Creating Formulas for Dietary Supplements ✓ Cost-Analysis and Procurement of Raw Ingredients ✓ Evaluating Technical Documents (COAs, Specifications, Non-GMO, etc.) ✓ Creating Supplement Facts ✓ Market Research and Competitive Analysis ✓ Creating Medical Content for Social Medias ✓ Writing Conference Reports ✓ Scientific Literature Research ✓ Writing Academic Medical Articles ✓ Writing Medical Books, Booklets and Brochures ✓ Writing Medical News and Blogs FEEBACK FROM CLIENTS "𝐀𝐝𝐢𝐥 𝐩𝐫𝐨𝐯𝐢𝐝𝐞𝐝 𝐝𝐢𝐥𝐢𝐠𝐞𝐧𝐭, 𝐭𝐡𝐨𝐫𝐨𝐮𝐠𝐡 𝐫𝐞𝐬𝐞𝐚𝐫𝐜𝐡 𝐢𝐧 𝐚 𝐭𝐢𝐦𝐞𝐥𝐲 𝐟𝐚𝐬𝐡𝐢𝐨𝐧, 𝐨𝐧 𝐚𝐧 𝐢𝐧𝐜𝐫𝐞𝐝𝐢𝐛𝐥𝐲 𝐭𝐢𝐠𝐡𝐭 𝐝𝐞𝐚𝐝𝐥𝐢𝐧𝐞. 𝐇𝐢𝐠𝐡𝐥𝐲 𝐫𝐞𝐜𝐨𝐦𝐦𝐞𝐧𝐝 𝐚𝐧𝐝 𝐈 𝐰𝐨𝐮𝐥𝐝 𝟏𝟎𝟎% 𝐰𝐨𝐫𝐤 𝐰𝐢𝐭𝐡 𝐡𝐢𝐦 𝐚𝐠𝐚𝐢𝐧." 🌟🌟🌟🌟🌟 "𝐀𝐝𝐢𝐥 𝐰𝐚𝐬 𝐞𝐚𝐬𝐲 𝐭𝐨 𝐰𝐨𝐫𝐤 𝐰𝐢𝐭𝐡, 𝐭𝐡𝐨𝐫𝐨𝐮𝐠𝐡, 𝐚𝐧𝐝 𝐡𝐚𝐝 𝐞𝐱𝐜𝐞𝐥𝐥𝐞𝐧𝐭 𝐜𝐨𝐦𝐦𝐮𝐧𝐢𝐜𝐚𝐭𝐢𝐨𝐧. 𝐇𝐞 𝐝𝐞𝐥𝐢𝐯𝐞𝐫𝐞𝐝 𝐭𝐡𝐞 𝐰𝐨𝐫𝐤 𝐞𝐚𝐫𝐥𝐲, 𝐚𝐧𝐝 𝐰𝐞𝐧𝐭 𝐚𝐛𝐨𝐯𝐞 𝐚𝐧𝐝 𝐛𝐞𝐲𝐨𝐧𝐝 𝐭𝐡𝐞 𝐰𝐫𝐢𝐭𝐭𝐞𝐧 𝐣𝐨𝐛 𝐝𝐞𝐬𝐜𝐫𝐢𝐩𝐭𝐢𝐨𝐧."🌟🌟🌟🌟🌟 "𝐀𝐦𝐚𝐳𝐢𝐧𝐠 𝐞𝐱𝐩𝐞𝐫𝐢𝐞𝐧𝐜𝐞. 𝐓𝐫𝐮𝐥𝐲 𝐠𝐫𝐞𝐚𝐭𝐟𝐮𝐥 𝐢 𝐰𝐚𝐬 𝐚𝐛𝐥𝐞 𝐭𝐨 𝐟𝐢𝐧𝐝 𝐡𝐢𝐦 𝐚𝐧𝐝 𝐡𝐞 𝐰𝐚𝐬 𝐬𝐮𝐩𝐞𝐫 𝐞𝐟𝐟𝐞𝐜𝐭𝐢𝐯𝐞 𝐢𝐧 𝐢𝐦𝐩𝐫𝐨𝐯𝐢𝐧𝐠 𝐦𝐲 𝐩𝐫𝐞𝐬𝐞𝐧𝐭𝐚𝐭𝐢𝐨𝐧. 𝐇𝐞 𝐞𝐯𝐞𝐧 𝐟𝐢𝐧𝐢𝐬𝐡𝐞𝐝 𝐰𝐚𝐲 𝐚𝐡𝐞𝐚𝐝 𝐨𝐟 𝐬𝐜𝐡𝐞𝐝𝐮𝐥𝐞."🌟🌟🌟🌟🌟 Let's collaborate to bring clarity and insight to your projects, ensuring top-quality results every time. Looking forward to hearing back from you discussing possible collaboration. Best, Adil
    vsuc_fltilesrefresh_TrophyIcon Drug Regulatory Affairs
    Virtual Assistance
    Content Writing
    Healthcare
    Scientific Research
    Online Market Research
    Scientific Literature Review
    Medical Records Research
    Technical Writing
    Academic Research
    Online Research
    Research Methods
    Academic Writing
    Pharmaceutical Industry
    Research Papers
    Science & Medicine
  • $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 Drug Regulatory Affairs
    Project Risk Management
    Vendor Management
    Company Policy
    Medical Device
    Document Review
    Document Management System
    Pharmaceutical Industry
    Internal Auditing
    Regulatory Compliance
    Procedure Manual
  • $36 hourly
    With over 14 years of extensive experience, I specialize in providing comprehensive services in the pharmaceutical, supplement, and cosmetic industries. My expertise encompasses: 💊Pharmaceutical product formulation and development, including pilot plant formulation to commercial formulation. 🧪Supplement product formulation and development across all dosage forms, including tablets, capsules, powders, and liquids. 💄Cosmetic product formulation and development, covering a wide range of products such as shampoos, creams, perfumes, and more. 🏭Industrial pharmacy services, ensuring adherence to GMP, ISO, HALAL, and FDA standards. 🏥Contract manufacturing services for supplements, food, and cosmetic products, offering end-to-end solutions from formulation to production. 🧑‍🏭Pharmaceutical cleanroom layout designing, costing, and consultation services. 🧑‍🔬Supplement private labeling compliance for E-retailer channels like Amazon. 💉Import-export consultation and services for pharmaceuticals, supplements, medical devices, and other healthcare items. 🧑‍⚕️Pharmaceutical engineering services, including equipment qualification and validation. ✅Content creation and comprehensive online/offline marketing services tailored to the healthcare industry. ✅Website development specializing in the pharma and health supplement sector, coupled with SEO and content writing services. In Regulatory Affairs: Specializing in regulatory submissions for pharmaceuticals, biologics, and medical devices, I excel in compiling, reviewing, and submitting regulatory documents to global health authorities, including the FDA, EMA, and PMDA. Proficient in developing CMC strategies and documentation for drug development, including INDs, NDAs, BLAs, IMPDs, and CTD submissions, ensuring compliance with regulatory requirements and industry standards. My professional journey spans over 11 years in the pharmaceutical and nutraceutical industry, where I have excelled as an industrial pharmacist. Leveraging this extensive experience, I offer expertise in formulating health supplements and pharmaceutical products, designing master formula records, and developing batch manufacturing records based on client specifications. In addition to my industry experience, I bring 7 years of tenure at DR REDDY'S LAB LTD (INDIA) pharmaceutical company, 1 year at ALKEM LAB LTD (INDIA) pharmaceutical company and 5 years in SINGAPORE based company manufacturing supplement and cosmetic products, further enriching my skill set and knowledge base. My primary skills include product formulation, development, equipment qualification, validation, process improvement, and troubleshooting. Whether you require assistance in cosmetic formulation and manufacturing or supplement formulation and manufacturing, I offer comprehensive solutions tailored to your specific needs. I also specialize in biotech product manufacturing factory setup, cosmetic product manufacturing facility setup, supplement product manufacturing factory setup, and herbal product manufacturing facility setup. Moreover, I provide services related to facility and utility setup, encompassing GMP review of pharmaceutical plants, pharmaceutical utilities requirements, facility development, production planning, inventory control, GMP documentation, facility and equipment qualification, process automation, and sourcing of herbal and active pharmaceutical ingredients.
    vsuc_fltilesrefresh_TrophyIcon Drug Regulatory Affairs
    Chemistry
    Mathematics
    Good Manufacturing Practice
    Product Development
    Social Media Advertising
    Product Formulation
    Product Stability
    Cosmetic Raw Materials
    Company Research
    Product Sourcing
    Food & Supplements
    Digital Marketing
    Business with 1-9 Employees
    Pharmaceutical Industry
    Science & Medicine
  • $25 hourly
    A licensed pharmacist and Master of Applied Biotechnology with expertise in bioinformatics, biopharmaceutics, drug delivery, drug discovery, and development. I am accustomed to writing and publishing Q1 and Q2 SCOPUS-indexed medical articles.
    vsuc_fltilesrefresh_TrophyIcon Drug Regulatory Affairs
    Citation Style
    Indonesian
    Literature Review
    Article Writing
    Grant Writing
    Academic Editing
    Scientific Writing
    Medical Writing
    Academic Writing
    SEO Writing
    Research Papers
    EndNote
    Proofreading
    Biotechnology
    Bioinformatics
  • $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 Drug 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
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