Hire a Freelance Regulatory Writer: Find an FDA Submission Expert

Dr. Marijn L.

Principal investigator | IRB member | Human neuropsychopharmacology of psychiatric disorders | Clinical trial specialist
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USD 100/hr
PhD, Neuropsychopharmacology
United States

I have close to 20 years of experience in human neuropsychopharmacological research at the Department of Psychiatry and Behavioral Sciences. I ...

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USD 100/hr
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Dr. Bishnupriya B.

Virologist and clinical trial specialist with 10+ years experience in basic science and clinical research
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USD 45/hr
United Kingdom

• Broad research and knowledge base in virology, molecular biology, drug target discovery, vaccine development, bioinformatics, antibody develo...

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USD 45/hr
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Dr. Dheeraj S.

Research Scientist/ Medical Writing/ Consulting/ Drug Screening/ Oncology/ Scientific Advisor/ Medical Reviewer
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USD 50/hr
Doctor of Philosophy (Ph.D)
Switzerland

An accomplished biomedical scientist with 7+ years of consulting & medical writing experience. Recognized for excellent scientific writ...

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USD 50/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 35/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 product analogous. Regulatory affairs Professional in pharmaceutical indu...

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USD 35/hr
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Dr. Nael A.

Physician | Medical Director | Clinical Development | Clinical Operations | Clinal Trials Management | CRO Management
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USD 150/hr
MBA
United States

Certified Principal Investigator and medical director with 12 years of experience in clinical operations and medical affairs. During my career,...

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USD 150/hr
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Dr. Dilip B.

Endorsed by the Royal Academy of Engineering as having exceptional Talent in Biomedical and Medical sciences
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USD 150/hr
PhD, Neuroscience
United Kingdom

I am the holder of highly prestigious Tier 1 Exceptional Talent Visa and endorsed as such by the Royal Academy of Engineering in the fields of ...

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USD 150/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. Mathew W.

Life Sciences Consultant, Writer, and Editor
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USD 60/hr
PhD in Biochemistry
Israel

I am a PhD enzymologist and protein biochemist with over 30 years experience in the biopharma and industrial biotechnology sectors, including 1...

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USD 60/hr
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Dr. Gloria V.

Pre-Clinical/Clinical Project Manager & Scientific Writer | 15 years experience in multidisciplinary R&D
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USD 60/hr
PhD
Switzerland

CV • Progressed from fundamental multidisciplinary research (Chemistry, Nanobiotech, Biochemistry) to in vitro Pharmacology (Cell Biology, Targ...

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USD 60/hr
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Dr. Archana N.

Freelance Medical Writer | specialising in drugs and devices | medical communications | CSRs, CERs, CSPs|Editing|
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USD 80/hr
PhD
Germany

I am Scientific and Medical Writer with 12+ years experience in academic research and writing. I have a Ph.D. in Genetics from one of the top t...

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USD 80/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. Dr akshay MD Senior medical writer A.

Senior Medical writer with 10 years experience( Research papers, systematic review, Meta analysis, literature reviews
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USD 40/hr
Dr
India

Medicine

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USD 40/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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Krishna K.

Medical Writer with Masters degree and 11+ years of experience in clinical research in multinational pharma companies.
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USD 40/hr
Master in Pharmacology
United Arab Emirates

Clinical Project Management and Medical Writing professional with 11+ years of experience in bio study activities including project planning, m...

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USD 40/hr
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Irene Y.

Regulatory affairs professional with extensive knowledge in ISO 13485:2016 and the EU MDR.
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USD 40/hr
Master of Business Administration
Malaysia

Regulatory technical writer with experiences in the medical device, pharmaceutical, and cosmetic industries. Demonstrate extensive knowledge in...

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USD 40/hr
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Diego G.

Food Scientist
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USD 25/hr
Food Science and Technology
Mexico

Food scientist specialized in consultancy for developing food products and the calculation of food labels with different compliances (FDA, mexi...

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USD 25/hr
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Loughlin G.

Microbiologist | SME in BioTechnology, Fermentation, High Throughput, Flavours, Regulatory Testing and Yeast Genetics
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Microbiology (MSc.)
United Kingdom

I studied Microbology (H. BSc) in University College Cork (U.C.C) where I wrote a review article on the Applications of Phage Therapy as an alt...

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Sundeep A.

Medical Device, IVD, QMS, CE Certificate, FDA 510(K), EU MDR, MDSAP, ISO 13485, SaMD, PMS, CER , PMCF, Risk Management
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USD 100/hr
Master of Technology - Quality Management
India

A seasoned professional with a decade of experience, I am a Leader and Speaker in the field of Quality Assurance & Regulatory Affairs, ...

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USD 100/hr
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Dr. Kanika S.

Certified Medical/Scientific Writer and editor
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USD 75/hr
Medical Writing
United States

I am a PhD-trained medical writer copyeditor with over 4 years of experience. I hold a graduate-level certification in Medical writing and edit...

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USD 75/hr
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Anjali S.

Experience in Clinical Research & Development, Pharmacovigilance, QAQC, Medical and Medico and content writing
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USD 50/hr
Masters in Pharmacology( M. Pharm)
India

Performance-driven professional with total 2 decades of rich & extensive experience in Clinical Research & Development, Pharmac...

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USD 50/hr
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Dr. Jasmien R.

PhD and postdoctoral experience in craniofacial genetics, experience as commercial translation consultant
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USD 75/hr
PhD
United States

Experience in craniofacial genetics, medical imaging on postdoctoral level. Experience in market research, intellectual property landscape and ...

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USD 75/hr
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Joshita M.

Biomedical Engineer, CMU | Product Manager & Medical Writer | Expert in Clinical Research with 9+ years of experienc...
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USD 30/hr
MS - Biomedical Engineering
Netherlands

A passionate researcher, with a Master’s degree in Biomedical Engineering from Carnegie Mellon University (USA), I have 9 years of product deve...

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USD 30/hr
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Stephane G.

Technical innovator - Medical Device Executive - Product development expert
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USD 160/hr
Ph.D. student
United States

R&D executive with a Masters in Plastics Engineering and 20 years of experience in the medical device industry; worked in both large-ca...

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USD 160/hr
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Dr. Rahul S.

Molecular Diagnosis and NGS clinical laboratory operations CLIA, CAP and FDA regulations. Natural ingredients.
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USD 200/hr
PhD
United States

Co-Founder of RetroBioTech, a consulting firm providing CAP-CLIA assay validation, FDA filing services, Shandi Ingredients developing nutraceut...

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USD 200/hr
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Alifiya T.

Clinical Research Scientist & Medical Writer with 5+ years of experience in academia & pharmaceutical industry
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USD 10/hr
Master of Public Health (Epidemiology & Biostatistics)
United States

I am a research scientist/medical writer trained in clinical sciences, epidemiology and biostatistics (BDS, MPH, Rutgers University, USA). My p...

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USD 10/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.