Hire a Freelance Regulatory Writer: Find an FDA Submission Expert

Dr. Ahmed E.

Freelance Medical Writer and Biostatistician with 5+ years of experience in clinical research
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USD 70/hr
PhD via MPhil Architecture, Computing and Engineering
United Kingdom

An MD with an onging Ph.D. in Healthcare Data Analytics....I have extensive experience within the scope of scientific writing, peer-reviewed publications, advisory...

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USD 70/hr
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Dr. Jonathan A.

Medical writer | Adjunct Prof., Faculty of Medicine, University of British Columbia | PhD, UC Berkeley | MBA, London
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USD 150/hr
MBA
Canada

Medical writer with experience in pharmacoeconomics, pharmaceutical policy, health policy, and health services research.

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USD 150/hr
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Dr. Nare S.

More than 10 years of experience as Regulatory Affairs Specialist, Medical and Scientific Writer, Clinical Trial Consult
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USD 50/hr
PhD in Pharmacy
Armenia

My science qualification is Ph.D. in pharmaceutical science. My writing qualifications: - Writing in the Sciences Certificate (Stanford Univers...

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USD 50/hr
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Dr. Harendra C.

Clinical NGS I Molecular Diagnostics । Virology I CLIA/CAP Lab Operations I Assay Validation I Antiviral Development
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USD 100/hr
PhD
United States

Experienced leader in research & development, laboratory operations and compliance, analytical assay development/validation with solid back...

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USD 100/hr
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Dr. Dillon H.

Research quantitative (data) analyst
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USD 185/hr
Economics, Ph.D.
Canada

I was accepted to the MAMF program at Columbia University in 2015 but chose for a variety of reasons to continue the economics doctoral program...

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USD 185/hr
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Dr. Jalal A.

A Ph.D. scholar at Tsinghua University and academic writer by profession.
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USD 30/hr
Ph.D., Chemistry
Pakistan

I'll write scientific articles or reviews, abstracts, summaries, and assist you in your thesis, format and proofread it. Being a doctoral ...

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USD 30/hr
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Dr. Souad M.

Clinical Operations, Clinical Trial Design, Regulatory Consulting, IND submission, Medical Writing
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USD 300/hr
PhD | Neuroscience
United States

I am a hard working and dedicated Clinical Researcher with 20 years of experience in clinical research in the fields of Neurology, Cancer, Card...

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USD 300/hr
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Dr. Diksha V.

Scientist & Writer | Expert in life science, cancer biology, drug discovery | Data science/analysis & bioinforma...
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USD 50/hr
PhD
India

I am a doctorate in life sciences with an experience of over 9 years in the academic and corporate sector. I have managed projects focusing on...

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USD 50/hr
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Denise A.

Experienced Regulatory Affairs Professional
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USD 150/hr
Masters of Science
United States

Hi, I'm Denise! I'm a Regulatory Affairs Professional with over 10 years of experience and a Master's Degree in Regulatory Affairs....

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USD 150/hr
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Dr. Abhay G.

Versatile Pharmaceutical Writer/Editor with Multiple Journal Articles
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USD 75/hr
Ph. D.
India

I am a pharmaceutical scientist (Ph.D.) with an extensive publication record, including multiple book chapters, peer-reviewed journal articles,...

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USD 75/hr
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Dr. VANOJAN M.

Doctor, Medical Writer and Editor
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USD 100/hr
MBA in Healthcare Administration
Sri Lanka

I am a medical doctor and a medical writer and editor for the past 8+ years. I have worked with many researchers, surgeons, dermatologists, nep...

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USD 100/hr
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Nida A.

Experienced MDD and MDR certified CER/Technical File Writer with 5+ years of experience with multinational industries
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USD 50/hr
BSC Biomedical Engineering
Pakistan

An experienced clinical research and medical device Technical file writer who has certified on MEDDEV 2.7/1 Rev#4 documentation, EU MDR, ISO-10...

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USD 50/hr
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Dr. Ahram Q.

Expert Life Science's Researcher, writer, and Consultant
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USD 50/hr
MPhil in Bioinformatics
Pakistan

My professional background is to technically write the Scientific content, assess the researcher in research work related to Bioinformatics and...

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USD 50/hr
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Dr. Nauman R.

Product Developer | Scientific Writer | Nutritional Scientist
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USD 20/hr
M.Sc. (Hons) Personalized Nutrition
Pakistan

Hello there! I'm Nauman, 24 years old, a registered dietitian by profession. I have completed my M.Sc. with a specialization in "Pers...

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USD 20/hr
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Dr. Hafsa I.

Medical Device Regulation (MDR) - BER - Technical File - CER - ISO13485 - Production manager - SOPs - Design File - GRIN
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USD 35/hr
PhD
Pakistan

Medical Device Production Manager with 5 years of experience in device development - Technical file - Design File - Procurement - Technology De...

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USD 35/hr
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Dr. Dhaval P.

Medical Writer with 5+ Years of Experience in Clinical Research
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USD 30/hr
PhD in Pharmacology
India

I am a PhD graduate with pharmacology specialization and have experience in handling clinical trial protocols, Clinical study reports, Manuscri...

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USD 30/hr
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Dr. Joyita B.

Freelance Materials Scientist and Consultant | Materials Science Editor
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USD 20/hr
PhD (Materials Science & Engineering)
India

I am a materials scientist. I earned my masters and doctorate degree in materials science and engineering from the Indian Institute of Science,...

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USD 20/hr
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Dr. Precious O.

Freelance Medical Writer with 5 year experience in Biomedical/Clinical Research
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USD 25/hr
Medical Degree (MD)
Nigeria

I am experienced in

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USD 25/hr
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Dr. Zia U.

Ph. D in Medicinal Chemistry | Regulatory affairs specialist and GMP compliance auditor | Researcher in Pharma Industry
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USD 95/hr
Synthesis, structural diversification, biological activities and biotransformation of dibenzylacetones: simple chemistry furnishing potent compounds
United States

Synthesis, semi synthesis, isolation and biotranformation of natural products analogous for the treatment of disease. Professional in pharmace...

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USD 95/hr
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Dr. GURDEEP SINGH S.

Development of regulatory compliant process technologies for API's, Speciality Organic, OLEDs and perfumery chemi...
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USD 50/hr
PhD (Chemistry)
India

I have hands on R & D exposure of 42+ years in the development of new synthetic methodologies for carbocyclic...and heterocyclic compounds, natural product as well as Organometallic Chemistry. ( 13 international publications...

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USD 50/hr
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Dr. Ana Luiza C.

Freelance Medical writer, Clinical specialist and Regulatory affairs of Medical Devices, Ph.D. Biological Sciences
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USD 69/hr
MBA Quality Management
Brazil

I have over 8 years of experience in Clinical Research, Regulatory Affairs and Quality Assurance of implantable and electro medical devices in ...

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USD 69/hr
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Dr. Maartje W.

Experienced Medical and Science Writer and Editor - Specialized in Oncology, Immunology, Gynecology, and Healthy aging
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USD 125/hr
PhD
Canada

I am a freelance medical and science writer with over 10 years of biomedical research and medical writing experience in oncology, immunology, a...

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USD 125/hr
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Dr. Julia J.

PhD in Biochemistry and Medical Writer with 20+ years of experience
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USD 50/hr
PhD
United States

As a scientist with over 20 years experience of project management, technical writing, teaching and the regulatory landscape; I have developed ...

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USD 50/hr
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Denise A.

Medical Device Global Quality and Regulatory Expert
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Bachelor's of Science and Associates of Business Administration
United States

I am an experienced Quality and Regulatory professional with over 25 years in the medical device manufacturing industry. I have worked with Cla...

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Dr. Sonika V.

Medical Writer and researcher having 10 years of post qualification experience in clinical and epidemiological research.
Contact
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USD 70/hr
Diploma in Applied Epidemiology
India

Experienced Medical Writer with a demonstrated history of working in the pharmaceutical industry and research organizations of international re...

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USD 70/hr
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Hire top FDA submission regulatory writers for help with regulatory writing to increase your chances of approval. Post your project securely and get quotes for free. Kolabtree is the world's largest platform for hiring trusted freelance consultants for regulatory writing services.

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How to Hire a Regulatory Writer

New drugs and medical devices need to navigate the complex maze of clinical trials and regulatory approval before they can go to market. In the process, a myriad regulatory documents need to be drawn up. With increasing numbers of drugs and medical devices being submitted for approval, there is a growing demand for regulatory documents that are compliant, scientifically sound, and well-written. Regulatory writing has, therefore, become a recognized niche within the pharmaceutical and medical device industries.

What Does a Regulatory Writer Do?

Regulatory writers work with regulatory agencies and various medical, technical, and operations professionals to draw up and review documents related to the different phases of clinical trials and market authorization. These documents need to adhere to the guidelines for Good Clinical Practice (GCP) according to the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH), and they need to conform to the requirements of the relevant regulatory agencies (e.g., FDA, EMA) and institutional review boards (IRBs).

The various documents that regulatory writers work on include:

  • Clinical study applications (CTAs)
  • Common technical documents (CTDs)
  • Investigational new drug applications (INDAs) and investigational medicinal product dossiers (IMPDs)
  • Clinical trial study reports (CSRs)
  • Marketing authorization applications (MAAs)
  • Integrated summaries of efficacy and safety
  • Periodic safety update reports (PSURs)
  • Informed consent forms
  • Risk management plans (RMPs)
  • Pediatric investigation plans
  • Proposed pediatric study requests
  • Pediatric use marketing authorizations (PUMAs)
  • New drug applications (NDAs)
  • Post-marketing documentation
  • Investigators’ brochures
  • Applications for orphan drug designations
  • Requests for product-specific waivers
  • Drafting response documents to address issues raised by regulatory agencies
  • Clinical evaluation reports (CERs)
  • Labeling regulatory documents (Summary of Product Characteristics, SmPC)

Experts in regulatory writing will typically be medical writers with several years of experience writing for a contract research organization (CRO) or pharmaceutical company. They usually have a PharmD, MD, or a Master’s or Ph.D. degree in an allied scientific field. They will have extensive knowledge of the regulatory requirements relevant to their region (e.g., FDA or EMA), as well as the ICH guidelines.

Regulatory writers work either as freelance medical writers or regulatory affairs consultants or for CROs, medical device or pharmaceutical companies, medical writing agencies, regulatory and governmental agencies, and regulatory affairs consultancies. The job titles of regulatory writing experts vary and can include Medical Writer, Regulatory Writer, Regulatory Submission Writer, Associate Medical Writer, Senior Regulatory Affairs Medical Writing Associate, and Senior Medical Writer. While some may be generalists, others may specialize in e.g., biologics or medical device regulatory writing.

How Much Does It Cost to Hire a Freelance Regulatory Writer?

To hire a freelance regulatory medical writer, the fee generally ranges from 40100 USD per hour depending on the required skillset and the level of experience necessary.

The hourly fee can be negotiated upfront based on the estimated number of project hours, or a flat fee (for projects of a defined scope) can be discussed. If you need short-term/temporary access to these specialists, then hiring a freelance regulatory writer or regulatory affairs consultant on our platform is a convenient and cost-effective way to harness their expertise.

How Do You Write an Effective Job Post to Hire an Expert Regulatory Writer?

The best way to attract the top Kolabtree freelancers in this field is to make your project description informative. You will need to provide information on the following:

  • Skills required (e.g., expertise in medical device regulatory writing)
  • What the project area is (e.g., development of a biorobotics device)
  • What the project entails (e.g., ensuring regulatory compliance with EMA and MDR guidelines)
  • What the deliverables are (be specific about what you need the outputs to be)
  • Duration of the project (provide an estimate of how many hours work you will need per week/by when you need the project to be completed)
  • By when you need to hire (having more leeway on this will give you more time to choose the best expert for your needs)
  • Your budget (per hour or fixed fee)
  • If you are unsure what exactly is required, providing as much detail as possible will allow the experts to still make an informed bid for your project and suggest the best routes forward.

Our platform makes it easier than ever before to connect and collaborate with regulatory medical writers and other regulatory affairs specialists.

Why Hire an FDA Submissions Expert

Working with an FDA submissions expert can help medical device, pharma and life science companies ensure that they meet all the requirements necessary for regulatory approval. Whether you're preparing a 510(k) or new drug (IND) submission, FDA consultants can provide guidance on best practices and mistakes to avoid. Working with consultants on demand can help you gain confidence at each stage of the entire submission process while also making it easier and quicker to obtain FDA approval.