Hire a Freelance Regulatory Writer: Find an FDA Submission Expert

Dr. Ahram Q.

Expert Life Science's Researcher, writer, and Consultant
Create Project
★★★★★
☆☆☆☆☆
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...

★★★★★
☆☆☆☆☆
USD 50/hr
Contact3

Dr. Julia J.

PhD in Biochemistry and Medical Writer with 20+ years of experience
Create Project
★★★★★
☆☆☆☆☆
USD 80/hr
PhD
United Kingdom

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

★★★★★
☆☆☆☆☆
USD 80/hr
Contact3

Dr. Kurtulus G.

Expert with 10+ Years of Experience in Medical, Scientific, Technical and Regulatory Writing
Create Project
★★★★★
☆☆☆☆☆
USD 100/hr
Ph.D. Biotechnology
United States

I am a freelance medical, scientific, and technical writer with high-quality researches at Harvard Medical School proven by research papers pub...

★★★★★
☆☆☆☆☆
USD 100/hr
Contact3

Dr. Nelson K.

Medical Writer with 10+ years of experience
Create Project
★★★★★
☆☆☆☆☆
USD 30/hr
PhD in Molecular Medicine
Kenya

I am a highly skilled and dedicated Professional Writer and Researcher with over 6 years of extensive experience in Medicine, Nursing, Biologic...

★★★★★
☆☆☆☆☆
USD 30/hr
Contact3

Dr. Nare S.

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

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

★★★★★
☆☆☆☆☆
USD 50/hr
Contact3

Dr. Michael L.

PhD expert in Engineerinr| Expert in Statistical analysis| Programming Expert
Create Project
★★★★★
☆☆☆☆☆
USD 50/hr
PhD - Electrical Engineering (Photonics)
United States

I am Dr. Michael, an accomplished academic with a Ph.D. in Engineering, specializing in statistical analysis and programming. My skill set incl...

★★★★★
☆☆☆☆☆
USD 50/hr
Contact3

Dr. Dillon H.

Research quantitative (data) analyst
Create Project
★★★★★
☆☆☆☆☆
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...

★★★★★
☆☆☆☆☆
USD 200/hr
Contact3

Dr. Dimitrios K.

Medical Writer & Market Research Consultant | Delivering Clear, Concise, Actionable Insights in Pharma & Biotech
Create Project
★★★★★
☆☆☆☆☆
USD 60/hr
Ph.D.
Cyprus

I'm a Freelance Medical Writer and Market Research Consultant. I provide Innovation Consulting, Market Research, and...Medical Communication services, including competitive intelligence, clinical trial materials, and study publications...

★★★★★
☆☆☆☆☆
USD 60/hr
Contact3

Dr. Jonathan A.

Medical writer | Adjunct Prof., Faculty of Medicine, University of British Columbia | PhD, UC Berkeley | MBA, London
Create Project
★★★★★
☆☆☆☆☆
USD 150/hr
MBA
United States

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

★★★★★
☆☆☆☆☆
USD 150/hr
Contact3

Dr. Zia U.

Ph. D in Medicinal Chemistry | Regulatory affairs specialist and GMP compliance auditor | Researcher in Pharma Industry
Create Project
★★★★★
☆☆☆☆☆
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...

★★★★★
☆☆☆☆☆
USD 35/hr
Contact3

Nida A.

Experienced MDR and FDA certified CER/Technical File Writer with 7+ years of experience with multinational industries
Create Project
★★★★★
☆☆☆☆☆
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...

★★★★★
☆☆☆☆☆
USD 50/hr
Contact3

Conor S.

Medical Writer | Clinical Pharmacist
Create Project
★★★★★
☆☆☆☆☆
USD 110/hr
Doctor of Pharmacy
United States

I am a US-based doctor of pharmacy with board certification in pharmacotherapy (BCPS). I bring a clinician's eye to your medical writing p...

★★★★★
☆☆☆☆☆
USD 110/hr
Contact3

Muniza J.

Social Scientist , Research Expert 8+ years, Statistical Analyst | Qualitative research Expert | Expert in Stata & S...
Create Project
★★★★★
☆☆☆☆☆
USD 50/hr
TOMER
Turkey

I am an Interdisciplinary Social Scientist, Keynote Speaker, Lecturer, PhD Scholar, and Research Expert with 8+ years of experience in the fiel...

★★★★★
☆☆☆☆☆
USD 50/hr
Contact3

Adam F.

exFDA Investigator / expert in Medical Device & Combination Product design, manufacturing, and compliance
Create Project
★★★★★
☆☆☆☆☆
USD 200/hr
Bachelors of Science in Biochemistry
Switzerland

I performed inspections and premarket approvals for FDA for 7.5 years. I am now a Senior Consultant operating out of Switzerland. I operate a...

★★★★★
☆☆☆☆☆
USD 200/hr
Contact3

Cristal R.

Medical doctor with 5+ years of clinical research, medical writing and biostatistical analysis experience.
Create Project
★★★★★
☆☆☆☆☆
USD 35/hr
Postgraduate in Principles and Practice of Clinic Research Program
Dominican Republic

I am a medical doctor holding a postgraduate in Principles and Practice of Clinical Research, accompanied by advanced expertise in biostatistic...

★★★★★
☆☆☆☆☆
USD 35/hr
Contact3

Joshita M.

Biomedical Engineer, CMU | Product Manager & Medical Writer | Expert in Clinical Research with 9+ years of experienc...
Create Project
★★★★★
☆☆☆☆☆
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...

★★★★★
☆☆☆☆☆
USD 30/hr
Contact3

Dr. Angela P.

Expert Biomedical Scientist and Scientific Editor and Writer
Create Project
★★★★★
☆☆☆☆☆
USD 70/hr
Ph.D.
United States

I am a highly skilled biomedical scientist with a Ph.D. in Cancer/Cell Biology and over 15 years of experience in biomedical research, data int...

★★★★★
☆☆☆☆☆
USD 70/hr
Contact3

Dr. JORDANA S.

Ph.D. student in pharmaceutical sciences ǀ Pre-clinical/Clinical studies ǀ Innovation ǀ Entrepreneurship ǀ Biotech
Create Project
★★★★★
☆☆☆☆☆
USD 10/hr
M.Sc. Physiological Sciences
Brazil

B.S. in biomedicine, M.S. in physiological sciences, and Ph.D. student in pharmaceutical sciences. I have experience in preclinical and clinica...

★★★★★
☆☆☆☆☆
USD 10/hr
Contact3

Dr. Brent R.

I sell FDA Compliant Drug Substance and Drug Product Quality and Performance Testing Programs & Guidance to FDA Appr...
Create Project
★★★★★
☆☆☆☆☆
USD 225/hr
Juris Doctorate
United States

I own a consulting firm with over 70 years of experience throughout the entire lifecycle of pharmaceutical submissions. We ensure your Drug Sub...

★★★★★
☆☆☆☆☆
USD 225/hr
Contact3

Dr. Javier G.

Experienced Medical Doctor and Freelance Medical Writer | Harvard-trained Researcher and Manuscript Writer
Create Project
★★★★★
☆☆☆☆☆
USD 150/hr
Medical Doctor
Mexico

I am a highly skilled medical doctor with a passion for medical research and writing....With a strong background in clinical research and an extensive publication record in indexed medical...

★★★★★
☆☆☆☆☆
USD 150/hr
Contact3

Dr. Gabriela L.

Medical writer | Scientific consultant | Biostatistics analyst
Create Project
★★★★★
☆☆☆☆☆
USD 25/hr
MSc in Pharmacology
Brazil

I have a master's and a doctorate in Pharmacology, a post-bachelor degree in Regulatory Affairs and a bachelor's degree in Pharmacy. I ...

★★★★★
☆☆☆☆☆
USD 25/hr
Contact3

Dr. Maria Chiara G.

MD, Ophthalmologist, PhD candidate
Create Project
★★★★★
☆☆☆☆☆
USD 35/hr
Regulatory Writing Certificate
Italy

I am an eye doctor and PhD candidate. I have experience in writing scientific papers, preparing presentations and reports. I will use my experi...

★★★★★
☆☆☆☆☆
USD 35/hr
Contact3

Adil M.

Researcher/ Writer/ Fact Checker/Data Curator & Data analyst
Create Project
★★★★★
☆☆☆☆☆
USD 20/hr
BSc (Hons) Molecular Genetics and Molecular Biology
Pakistan

Dear Employers, I am a Professional researcher, writer, fact-checker, and analyst with a Master's Degree in Molecular Biology. My natural...

★★★★★
☆☆☆☆☆
USD 20/hr
Contact3

Vandita S.

Natural Product Chemist with 25 years industry experience in Dietary Supplements, Nutraceuticals, Food, Drug Discovery
Create Project
★★★★★
☆☆☆☆☆
USD 200/hr
Ph.D. Medicinal Chemistry
India

 Expertise in Development of innovative, green & cost effective products & processes for Nutraceuticals, Dietary supplements, Cosmetic...

★★★★★
☆☆☆☆☆
USD 200/hr
Contact3

Darshan D.

Medical Writer || Clinical Researcher || Market Researcher || Digital Marketer || Health-Tech Start-up Consultant
Create Project
★★★★★
☆☆☆☆☆
USD 50/hr
Master in Pharmacy
India

Seasoned Pharma Professional (12+ Years) with a demonstrated history of working in diversified profiles from a registered pharmacist, Productio...

★★★★★
☆☆☆☆☆
USD 50/hr
Contact3

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.

pay-per-click
Confidentiality Assured

We take several measures to help you work with full confidence and peace of mind.

Keep your project private

Restrict who can see your project and send you proposals. Invite only specific freelancers to view your project.

NDAs and IP protection

Our T&C include a default confidentiality clause that protects your IP and NDA for added protection before disclosing project details.

Kolabtree ensures safety and security of your payments and personal information and project details. Kolabtree’s T&C includes a default confidentiality and NDA clause.

You will receive detailed proposals directly from Kolabtree. These proposals will include a comprehensive Statement of Work (SOW), project fees, milestones, and deadlines.

You can choose to pay either a fixed or an hourly fee based on your scope of work. Pre-pay for the next milestone. You have to approve the deliverables only if the quality meets your expectations. If you arn’t happy, we’ll refund your money.

Kolabtree will share multiple quotations for your project. You have the freedom to accept the quote that aligns with your project requirement and budget. You can get in touch with us in case you want to discuss the fee.

Our T&C include a default confidentiality clause that protects your IP and NDA for added protection.

Why Kolabtree

Contact experts directly

Speak directly with freelancers and explain your requirements.

100% satisfaction guaranteed

You have to approve the deliverables only if quality meets your expectations. If you arn’t happy, we’ll refund your money.

Project Management

Keep track of files and conversations in the user-friendly Workspace.

Flexible, secure payments

You can choose to pay either a fixed or an hourly fee based on your requirement.

Recent Projects
  • Hiring for fda regulatory affairs consultants
    $550.00
  • Need to outsource a fda regulatory affairs expert
    $450.00
  • Looking for a regulatory writer for mini project
    $450.00
  • Senior regulatory medical writer required for a complex project
    $500.00
  • CMC regulatory writer needed
    $550.00
How it works View full page
1

Post your Project (Free)

Your project details are safe, secure and visible only to logged-in users.

2

Get Quotes & Choose Experts

Discuss your requirements in detail with the experts before accepting the final statement of work from Kolabtree.

3

Collaborate

Pre-pay for your project and work with the expert to get your desired output. Keep track of files and conversations in the user-friendly Workspace.

4

Job Done!

Approve the deliverables once you're satisfied with the job done.

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.