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. GURDEEP SINGH S.

Development of regulatory compliant process technologies for API's, Speciality Organic, OLEDs and perfumery chemi...
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USD 100/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 100/hr
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Dr. Kelvin C.

Professional freelance| Expert in Mathematics, Engineering Statistics with 8+ Years experience
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USD 80/hr
PhD Mathematics
Kenya

As a highly skilled professional with a PhD in Mathematics, an MSc in Computer Science, and a BSc in Engineering, I have a broad range of exper...

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USD 80/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. Dillon H.

Research quantitative (data) analyst
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USD 200/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 200/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. Nael A.

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

Physician with over 12 years of clinical operations experience. Skilled in all aspects of clinical research support including trial management,...

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USD 150/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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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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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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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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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
Law (LLB Honours)
Pakistan

An experienced clinical research and medical device Technical file writer who has certified on MEDDEV 2.7/1 Rev#4 documentation, EU MDR 2017/74...

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USD 50/hr
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Muhammad A.

A Team of Specialists in Creative, Medical, Technical & SEO Writing, Articles/Blogs, Copywriting, Editing & Proo...
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USD 50/hr
Electrical Engineering
Pakistan

Greetings, Welcome to our hub of professional writing and research, where a dedicated team with over five years of solid experience provides ...

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USD 50/hr
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Dr. Dimitrios K.

Medical Writer / Market Research / Business Intelligence
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USD 60/hr
Ph.D.
United States

As the medical writer and sole trader of DEKAOKTO solutions, I offer MedComms services, including publication, market research, and conference ...

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USD 60/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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Didy Yoga Lucky P.

I am a Pharmacist. I am well versed in pharmaceutical science and cosmetics, whether it is natural or synthetic medicine
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USD 40/hr
Apt
Indonesia

I have experience in in vitro, in vivo, in silico study, analytical of plant extract, and isolation of metabolite. I also have written study to...

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USD 40/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. Pranesh B.

Scientific Content editing, Literature search & curation, Regulatory approvals, Technology prospecting
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USD 50/hr
Ph.D
India

Scientific Literature content review; editing, pre-publication refinement, curation, report authoring. Competitive intelligence; Technology pr...

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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. Arinzechukwu U.

Freelance Scientific Writer and Consultant with over 6+ years in cancer research
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USD 100/hr
Molecular Haematology
United Kingdom

I have over 10+ years experience in medical/content/copywriting and proof-reading/editing as well as over 6+ years experience in cancer researc...

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USD 100/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. Shilpee S.

Scientific and Medical writer
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USD 35/hr
PhD in Biology
India

I have many years of experience in biochemistry, molecular biology, and bioinformatics with an emphasis on enzymes and other metabolic proteins...

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USD 35/hr
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Dr. ANATH L.

Founder/CEO at DADYMINDS
Contact
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USD 25/hr
NATIONAL TVET CERTIFICATE V
Rwanda

5 years in research and writing as an influential author| Expert in business management and mental health services| Plus expertise in Global Br...

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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
Contact
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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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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.