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Check out Drug Regulatory Affairs professionals with the skills you need for your next job.
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  2. Writing & Translation Talent
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  4. (Current) Drug Regulatory Affairs Freelancers
  • $160 hourly

    • 5.0/5
    • (261 jobs)
    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.
    vsuc_fltilesrefresh_TrophyIcon Drug Regulatory Affairs
    Product Label
    Legal
    Drug Regulation
    Cosmetics
    Food & Supplements
    Regulatory Compliance
    Label Compliance
    Medical Device
    Compliance
    Quality Assurance
    Legal Consulting
    Technical Writing
  • $75 hourly

    • 5.0/5
    • (58 jobs)
    - 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
    vsuc_fltilesrefresh_TrophyIcon Drug 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
  • $25 hourly

    • 4.6/5
    • (69 jobs)
    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💡
    vsuc_fltilesrefresh_TrophyIcon Drug Regulatory Affairs
    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
  • $350 hourly

    • 4.9/5
    • (65 jobs)
    **AVAILABLE TO ASSIST WITH NEW COSMETIC REGISTRATION & LISTING REQUIREMENTS, ANNOUNCED 07 AUG 23** ** 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 Drug Regulatory Affairs
    Label Design
    Drug Regulation
    Food & Supplements
    Compliance
    Product Label
    Cosmetic Regulation
    Regulatory Compliance
    Label Compliance
    Medical Device
    Medical Device User Manual
  • $13 hourly

    • 4.9/5
    • (534 jobs)
    I am a pharmacist by profession and a writer/translator by passion. I hold a Master's in Regulatory Affairs and Health Policy from Massachusetts College of Pharmacy, USA. Currently, I am with the Ministry of Public Health, Thailand where I serve as a pharmacist and a subeditor for a scientific journal named Pharmacopoeial Newsletter. Meanwhile, I am a freelance translator. I am specialized in translating medical, pharmaceutical and scientific documents. I also do general translations and I can tailor my writing styles to fit the unique needs of a particular client. I can translate both TH-EN and EN-TH, as well as writing creative/specific content in both languages, your choice. Additionally, I am also interested in working as a personal/virtual assistance or any job that requires communication. I am flexible, yet reliable. I am always open to any suggestions and comments from my clients. My goal is to serve my client with high quality work and optimum satisfaction. The rate is negotiable since I am not doing this just for living but to fulfill my passion.
    vsuc_fltilesrefresh_TrophyIcon Drug Regulatory Affairs
    Pharmaceutical Industry
    English to Thai Translation
    Medical Translation
    Drug Regulation
    Thai to English Translation
    Creative Writing
    Copywriting
    Writing
    Language Interpretation
    Academic Translation
    Thai
    Live Interpretation
  • $175 hourly

    • 4.6/5
    • (47 jobs)
    Highly motivated Product Formulation Expert and Regulatory Affairs Expert in the following fields: Medical Devices ,Pharmaceuticals ,Dietary Supplement DEMONSTRATED EXPERTISE IN : MEDICAL DEVICES Demonstrated Expertise in the following fields in a contractor capacity for over 5 years as a freelancer - Consulting services in the areas of medical device regulation and prescription including quality systems, clinical trials, TGA product registrations, FDA submissions, CE marking, EU MD Registrations. -ISO13485 AND QMS Gap Analysis and Auditing Specializes in - Class 1 , Class 2 and 510(k) Submissions - OTC and Clinical With market expertise in United States ,Canada ,Australia ( TGA) ,New Zealand United Kingdom ,European Union 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. *Part of HealthREG Solutions Group and RX Medical Global Connect with me on What's App or Telegram +61413771936 , lisa@healthregsolutionsgroup.com.au
    vsuc_fltilesrefresh_TrophyIcon Drug Regulatory Affairs
    Legal Consulting
    Regulatory Intelligence
    Medical Device
    Food & Supplements
    Cosmetic Regulation
    Regulatory Compliance
    Product Formulation
    Drug Regulation
    Product Development
    Retail & Consumer Goods
  • $15 hourly

    • 5.0/5
    • (6 jobs)
    Hello Upwork community. Its Muhammad Hassan, a dedicated and committed freelancer and PhD scholar of Biochemistry. I have been doing freelancing as a scientist and researcher since 2019. Compiled good number of scientific survey, editing, analysis, articles, blogpost, dissertation (editing, proofread), and many more. I can provide you scientific analysis work, blogpost, expert opinion and data interpretation services, below is some description of my portfolio. 1. Chemistry (organic, inorganic, spectroscopy etc.) (FTIR, NMR, MS, UV-vis) 2. Biochemistry (Molecular biology, genetics, biotechnology, cancer biology) 3. Medicinal chemistry (Synthetic chemistry, drug analysis, drug synthesis) 4. Pharmaceutical chemistry, pharmacy, medicine 5. Virology, COVID-19, Ebola etc 6. Cancer Biology 7. Health articles 8. Genetics 9. Biotechnology 10. Medical articles ( cardiac, health, neurologic, cancer, diabetes etc Expertise in Data analysis I have great expertise in statistical analysis, survey questionnaire analysis, proof reading, summaries questionnaire development. I use MINITAB. MATLAB, SPSS, R etc. Services included 1 Qualitative analysis, 2 Quantitative analysis 3 Mixed method analysis 4 Descriptive statistics 5 Hypothesis, ANOVA, Regression 6 Forecasting 7 Trend 8 Time series Services available 1 Long short articles and blogpost 2 Fully referenced (APA, Harvard, Vancouver, MLA etc) 3 Data analysis 4 Statistical analysis 5 Original work/no copy past Please discuss with me about your projects, I will definitely provide quality work and will do more as per your expectations.
    vsuc_fltilesrefresh_TrophyIcon Drug Regulatory Affairs
    Data Science Consultation
    Writing
    Scientific Literature Review
    Dissertation Writing
    Drug Regulation
    Minitab
    IBM SPSS
    Statistical Analysis
    Data Analysis
    Microbiology
    Pharmaceuticals
    Chemistry
    Biomedical Engineering
    Biochemistry
    Science & Medicine
  • $100 hourly

    • 5.0/5
    • (5 jobs)
    Over 10+ years of experience in doing regulatory submissions in US, EU, Canada and ROW. Can help with other regulatory needs as well like labeling and marketing material review, creating regulatory strategies, communication with the regulatory agencies, creating regulatory procedures and SOPs, post-market regulatory support, etc. Looking to help small to mid scale companies with their regulatory needs. Can provide competitive pricing and focused attention to each client.
    vsuc_fltilesrefresh_TrophyIcon Drug Regulatory Affairs
    Product Label
    Regulatory Intelligence
    Medical Device
    Document Review
    Label Compliance
    Writing
    Regulatory Compliance
    Shipping Labels
  • $45 hourly

    • 5.0/5
    • (8 jobs)
    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.
    vsuc_fltilesrefresh_TrophyIcon Drug Regulatory Affairs
    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
  • $30 hourly

    • 5.0/5
    • (6 jobs)
    Specialists in regulatory affairs for medicines, biological and medical device for global market including EU and US. I have experience in preparing and managing dossier for new market approval application (NDA, ANDA, 510k, de novo) and license maintenance activities like renewals, variations, health agency questions and annual reports. I have experience of 10years in regulatory affairs.
    vsuc_fltilesrefresh_TrophyIcon Drug Regulatory Affairs
    Drug Regulation
    Medical Device
  • $20 hourly

    • 4.9/5
    • (85 jobs)
    About me: Working for last 15 years in the pharmaceutical industry, healthcare, and Digital Marketing, 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, graphics development. Have working experience in more than 15 countries from central Europe to South Asia. Have created materials and marketing entry plans for several large pharmaceutical and healthcare multinational companies (Searle, Shreya, Mega life sciences, Indian Immunologicals etc.), both scientific and promotional. Education: M.D. (general medicine), FID (fellowship in diabetes), certificate courses in project management, neurology, infectious diseases. Languages: English and Russian Other: lifetime member Indian Medical Association
    vsuc_fltilesrefresh_TrophyIcon Drug Regulatory Affairs
    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
  • $175 hourly

    • 4.8/5
    • (31 jobs)
    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
    vsuc_fltilesrefresh_TrophyIcon Drug Regulatory Affairs
    Statistical Computing
    Multivariate Statistics
    Linear Regression
    Logistic Regression
    Scientific Research
    Statistical Programming
    Biostatistics
  • $15 hourly

    • 4.9/5
    • (40 jobs)
    Energetic and Self Motivated Freelancer with years of experience in providing Administrative Support to Companies across the Globe Specialized in Admin Support, Virtual Infrastructure Specialist Customer Relation Management, WordPress Website Management, Email Management & Marketing, Social Media Managmement, E-Commerce Business Setup, and Management, I am a quick learner and fully aware of all the task an Admin Assistant has to manage, I have a Vast knowledge of Internet skills and have hands-on a variety of different platforms and can handle many simple and complex tasks. I can help you develop your business and I can effectively provide you my services in the following areas: ✅Admin Support, ✅Calender Management ✅Travel Arrangements ✅Meeting Scheduling ✅General Record-Keeping, Collection, and Analyzing of Data ✅Search engine optimization ✅Social Media Managment ✅Social Media Content Creation ✅Search engine marketing ✅WordPress Website Management, ✅Email Management & Marketing, ✅E-Commerce Business Setup, and Management, ✅Amazon FBA (PPC , Listing Optimization, Product Listing, Product Description) ✅Social Media Management ✅Product Marketing (Facebook, Instagram, Twitter, ✅E-Commerce Store Handling (Amazon, eBay, Shopify Store) ✅Website Content SEO and Optimization I have immense knowledge in handling Digital Marketing by keeping a relationship of commercialism and can face any kind of improbability and unpredictability very much tactfully. I am aware of the new skills and technology being used. I keep My Self Updated with new information on technologies and platforms which can help a business grow, I am good at finding Inventive Solutions and Capable of Doing other works such as Website Designing, Amazon Seller Center, Network support, and user support. I have taken full-fledged training in Computer Administrative Operations And VA Services. I have professional skills in Virtual Assistance, Website Designing, E-commerce Store Management, Social Media Marketing, and any kind of online Research work. I can easily manage work related to data entry, admin support, Virtual Assistance effectively. I’m an Organized Person and Have Excellent Communication Skills. I can explain a person well about the problem and Different Tasks I am an easy person to get along with I can assure you that I can prove myself beneficial to your organization. I am always keen to learn more associated with my job. My motive is to learn my job more precisely with practices and bring appeasement in the fair face of my clients. Feel free to contact me for further discussions. Qamar Danish
    vsuc_fltilesrefresh_TrophyIcon Drug Regulatory Affairs
    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
  • $25 hourly

    • 5.0/5
    • (12 jobs)
    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
    Scientific Literature Review
    Literature Review
    Article Writing
    Grant Writing
    Academic Editing
    Academic Research
    Scientific Writing
    Medical Writing
    Academic Writing
    SEO Writing
    Research Papers
    EndNote
    Proofreading
    Biotechnology
    Bioinformatics
  • $35 hourly

    • 4.7/5
    • (38 jobs)
    12 years of experience in offering Services: ☑ Pharmaceutical formulation, ☑ Supplement product formulation and development in different dosage form, ☑ Cosmetic product formulation and development in different dosage form, ☑ Industrial Chemist, ☑ GMP audit services, ☑ Contract manufacturing, ☑ Pharmacist, ☑ Private labelling Amazon, ☑ Pharmaceutical/supplement/other healthcare item sourcing expert ☑ Medicine/healthcare item import/export, ☑ Medical device, ☑ Healthcare business consultation, ☑ Website development for pharma and health supplement industry, ☑ SEO and content writing for supplements/cosmetic products ☑ Pharmaceutical Validation, ☑Equipment qualification, ☑Pharmaceutical expert, I am a professional freelance for creating the new formula of health supplements & Pharmaceutical products; I develop the pilot plant formulation to the commercial formulation. I have 11 years of experience in the pharmaceuticals and nutraceutical industry. I worked as an industrial pharmacist. Based on my experience, I can develop the formula for health supplements and pharmaceuticals products. For Pharmaceuticals products, I can design the MASTER FORMULA RECORD and can develop the BATCH MANUFACTURING RECORD based on the ingredients list. If you don't have the Ingredients list for the formula, I can suggest the list of ingredients based on your customer target. After formulating the product, I can provide you the CONTRACT MANUFACTURING for the designed products. It would be best if you share target price. I have seven years of working experience in the DR REDDY'S LAB LTD (INDIA), 5 Months of working experience in the ALKEM LAB LTD (INDIA), and 3 Years of working experience in the VITTAPHARMA PTE LTD (SINGAPORE). My primary Skill is product formulation, Product development, Equipment qualification, Product validation, Process Validation, Equipment troubleshooting, process improvement. Cosmetic formulation and Manufacturing: shampoo, cream, perfume, toothpaste, hand sanitizer, face mask, conditioner, mouthwash, sunscreen. Supplement formulation and manufacturing: 1. All kinds of supplement formulation like a tablet, capsule, powder for suspension & Liquid. Have establishment of different pharmaceutical, Biotech, supplement manufacturing facility. Biotech product manufacturing factory setup. Cosmetic product manufacturing facility setup. Supplement product manufacturing factory setup. Herbal product manufacturing factory setup. Facility & Utility Setup:- 1. GMP review of Pharmaceutical plant. 2. Pharmaceutical Utilities requirement based on products. 3. Facility development based on products like Tablet production line, capsule production line, powder for suspension production line, Ointment production line, sachet product line. 4. Production Planning and inventory control. 5. GMP Documentation. 6. Facility qualification. 7. Equipment qualification. 8. Process automation for pharma. 9. Product, process, and area qualification. 10. Sourcing of herbal ingredients and active pharmaceutical ingredients.
    vsuc_fltilesrefresh_TrophyIcon Drug Regulatory Affairs
    Good Manufacturing Practice
    Product Development
    Social Media Advertising
    Product Formulation
    Product Stability
    Cosmetic Raw Materials
    Company Research
    Private Labeling & White Labeling
    Contract Manufacturing
    Product Sourcing
    Food & Supplements
    Digital Marketing
    Business with 1-9 Employees
    Pharmaceutical Industry
    Science & Medicine
  • $15 hourly

    • 5.0/5
    • (35 jobs)
    • More than 5000 hours web research experience in a number of areas • Quick learner. Active, flexible and always in a mood for work. • I enjoy creative writing and I'm pretty good at it. • Microsoft Excel, Word, PowerPoint, Google sheets
    vsuc_fltilesrefresh_TrophyIcon Drug Regulatory Affairs
    Lead Generation
    Product Research
    Industry Research
    Article Writing
    Review
    Topic Research
    Microsoft Excel
    Data Entry
    Microsoft Word
    Creative Writing
  • $55 hourly

    • 5.0/5
    • (21 jobs)
    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
    Medical
    Academic Editing
    Scientific Research
    Human Science
    Content Writing
    Blog Writing
    Manuscript
    APA Formatting
    Biotechnology
    Scientific Writing
  • $120 hourly

    • 5.0/5
    • (7 jobs)
    Hi! I am a professional food scientist/timber farmer able to help with product development and quality projects. I've worked in both quality and R&D in various food industry settings, from the largest winery in the world to a small start-up spice company. I love all parts of R&D, from benchtop product formulation to ramping up the recipe for large-scale production. Supplement gummies, spice blends, wine and other alcohol beverages and spirits, candy, baked goods, sausages and cheeses are some of the products I have had a lot of experience developing. I also take food quality and food regulations seriously and can help your company prepare for the many stages of FSMA compliance. I'm not someone who needs a lot of direction - once we discuss the project, I will come back with questions, and once those are answered you can expect the project to be delivered quickly.
    vsuc_fltilesrefresh_TrophyIcon Drug Regulatory Affairs
    Food Engineering
    Process Safety
    Product Development
    Nutrition
    Product Formulation
    Recipe Development
    Research & Development
    Quality Assurance
    Retail & Consumer Goods
    Food & Supplements
    Quality Control
    Regulatory Compliance
    Food & Beverage
    Researcher
  • $26 hourly

    • 4.8/5
    • (169 jobs)
    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) 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. Undertake accounting, book keeping outsourcing projects.
    vsuc_fltilesrefresh_TrophyIcon Drug Regulatory Affairs
    Business Plan
    Flowchart
    ISO 9001
    ISO 27001
    Market Research
    ISO 9000
    Business Process Modeling
  • $12 hourly

    • 4.5/5
    • (89 jobs)
    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. Accounting/Bookkeeping Software: Quickbooks Desktop, Quickbooks Online, Xero, Wave, Zoho Books Certifications: Quickbooks Desktop Certified, Quickbooks Online Certified 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 Drug Regulatory Affairs
    Basecamp
    Xero
    Property Management
    Buildium
    Trello
    Bookkeeping
    Email Marketing
    Ecommerce
    AppFolio
    Google Workspace
    Social Media Marketing
    Intuit QuickBooks
  • $300 hourly

    • 5.0/5
    • (6 jobs)
    A physician with an education and work history in computer engineering. I consult MedTech startups with strategy, use cases, product direction and execution. I bring technical perspective to these strategies while helping companies achieve a high level of utility and product value from their development efforts. I help build valuable software and hardware products in the complex legal and operating environment of healthcare. My consulting typically falls into three categories: Leadership: I join leadership teams at different times in a company’s growth cycle to strengthen (or shore up) a company's strategy. My medical, technical, and patient experiences bring insight to strategy sessions that ultimately create products that help solve healthcare problems. Technical: My technical career started after finishing electrical and computer engineering at Carnegie Mellon. In four years I became a Design Engineer II at AMD (Advanced Micro Devices). Today, I practice modern software development philosophies where I help companies transform the healthcare industry with technology. I work heavily in and around EHRs, medical data, and the interoperability challenges of the industry. I work at the strategy level as well as lead projects and teams during critical intervals. Clinical: After Tufts Medical School, I became knowledgeable in the Cures Act and its subsequent Interoperability Proposal as a basis for understanding the operating environment. I successfully led athenahealth through the 2015 Meaningful Use Certification. I continually translate medical processes into digital environments so companies build products that users need. I have an extensive medical patient background. With an undiagnosed illness (now well-controlled), I witnessed first-hand the complexities, waste and absurdities of our medical system. That experience provides me with perspective about the opportunity technology will play in the future of healthcare. My engagements and fees vary based on a project’s length and involvement. I joined Upwork in 2021 to gain exposure to more medical technology solutions that inspire me.
    vsuc_fltilesrefresh_TrophyIcon Drug Regulatory Affairs
    Data Ingestion
    Data Modeling
    Technical Writing
    Epic Systems Medical Software
    Medical Billing & Coding
    Software Design
    Electronic Medical Record
    Business Strategy
    Information Security
    Electronic Medical Record
    Telemedicine
    Product Management
    QuickBase
    IT Consultation
  • $60 hourly

    • 4.9/5
    • (162 jobs)
    A physician, manager and chemist with twenty four years of experience in medicine, new business development, market analysis, sales, organic synthesis, solvent design, organometallic synthesis and catalysis, designing oil and gas drilling products, technical service and cleaning product formulation. Major strengths include: • Initiating and sustaining new business ventures and relationships • Creating products and services which solve customer problems • Providing effective leadership to a national chemical sales team • Managing distributor relationships • Advising customers implementing new formulations • Enhancing customer plant performance • Organic and organometallic chemical synthesis • Optimizing catalyst performance • Design of novel solvents compliant with environmental regulations
    vsuc_fltilesrefresh_TrophyIcon Drug Regulatory Affairs
    Business Development
    Science & Medicine
    Scientific & Technical Services
    Cosmetics
    Research Papers
    Nutrition
    Business Coaching
    Organic Chemistry
    Academic Writing
    Chemistry
    Business Writing
    Biology
    Business Management
  • $34 hourly

    • 5.0/5
    • (70 jobs)
    With over 10 years' experience in my 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. With published articles. • Unlocking Insights: Medical Records Review and Summarization for Comprehensive Healthcare and Academic Analysis • 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. • Comprehensive Market Research Analysis of the Medical Field: Key Trends, Growth Opportunities, and Competitive Landscape.
    vsuc_fltilesrefresh_TrophyIcon Drug Regulatory Affairs
    Product Formulation
    Chemistry
    Scientific Writing
    Science & Medicine
    Academic Writing
    Technical Writing
    Data Entry
    Academic Research
    Pharmaceutical Industry
    Administrative Support
    Medical Records Research
    Research Methods
    Scientific Research
    Online Market Research
    Online Research
  • $120 hourly

    • 5.0/5
    • (55 jobs)
    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
    Supplier Development
    Policies & Procedures
    Procedure Manual
    Document Management System
    Project Risk Management
    Document Review
    Pharmaceutical Industry
    Internal Auditing
    Regulatory Compliance
    Medical Device
  • $75 hourly

    • 4.9/5
    • (18 jobs)
    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.
    vsuc_fltilesrefresh_TrophyIcon Drug Regulatory Affairs
    Writing
    Process Safety
    English
    Business Services
    Financial Audit
    Training Materials
    Content Writing
    Training Plan
    Food & Beverage
    Training & Development
    Regulatory Compliance
    Audition Preparation
    Training Design
  • $40 hourly

    • 4.8/5
    • (133 jobs)
    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
  • $185 hourly

    • 4.9/5
    • (1,169 jobs)
    I am a full-service, NY & NJ licensed attorney with 10+ years of experience and a highly-respected specialist in providing affordable and quality legal services. I am expert in contract drafting, reviewing, editing, redlining & advising; labor & employment law; negligence & liability; dispute resolution; IP protection; pleading drafting; litigation support; and comprehensive research on all legal topics. I hold advanced degrees from Vermont Law & Graduate School (J.D. 2014; LLM, 2014) and Seton Hall University (MPA, 2011; BA, 2005). I am a hardworking professional willing to go the extra mile for all of my clients!
    vsuc_fltilesrefresh_TrophyIcon Drug Regulatory Affairs
    Legal Research
    Corporate Law
    Contract Negotiation
    Contract Law
    Legal Writing
    Contract Drafting
    Nonprofit Organization
    Policy Writing
    Business Services
    Legal Consulting
    Copy Editing
    Workplace Safety & Health
    New York State Bar Association
    New Jersey State Bar Association
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