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
MPhil PhD Student
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. Maartje W.

Experienced Medical and Science Writer and Editor - Specialized in Oncology, Immunology, Gynecology, and Healthy aging
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USD 150/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 150/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. Shyam Nikethen G.

Medical writer with expertise in producing Regulatory compliant CSR, protocols and SAE reports and Summaries
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USD 10/hr
PharmD (Doctor of Pharmacy)
India

With immense knowledge on Adverse Drug Reaction(ADR) monitoring and reporting, patient care, counselling, prescription monitoring, drug interac...

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USD 10/hr
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Dr. Kurtulus G.

Expert with 10+ Years of Experience in Medical, Scientific, Technical and Regulatory Writing
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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...

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USD 100/hr
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Dr. Nelson K.

Medical Writer with 5+ years of experience
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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...

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USD 30/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 a Ph.D. in pharmaceutical science. My writing qualifications: - Writing in the Sciences Certificate (Stanford Unive...

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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. Dimitrios K.

Medical Writer & Market Research Consultant | Delivering Clear, Concise, Actionable Insights in Pharma & Biotech
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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...

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USD 60/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
United States

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. VANOJAN M.

Doctor, Lecturer, Medical Writer and Editor
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USD 75/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 75/hr
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Dr. Diksha V.

Researcher & Writer with 11+ years of experience in biotechnology, biomedical, bioinformatics and product developmen...
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USD 100/hr
PhD
India

I am a doctorate in life sciences with an experience of over 11 years in the academic and corporate sector. I have managed projects focusing o...

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USD 100/hr
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Dr. Stuart C.

Scientist/Consultant w/R&D & Manufacturing Expertise in Pharmaceutical/Nutraceutical/Food/Cannab...
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USD 150/hr
Ph.D. Pharmaceutical Sciences
United States

Pharmaceutical/Nutraceutical/Food Formulation Scientist with 30+ years of experience developing soft chews, tablet and capsule products, chewab...

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USD 150/hr
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Nida A.

Experienced MDR and FDA certified CER/Technical File Writer with 7+ 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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Conor S.

Medical Writer | Clinical Pharmacist
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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...

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USD 110/hr
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Adam F.

exFDA Investigator / expert in Medical Device & Combination Product design, manufacturing, and compliance
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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...

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USD 200/hr
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Morgan B.

Medical writer with 7+ years of experience in clinical research
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USD 40/hr
MS
United States

Freelance writer with over 7 years in clinical research. I've been involved in medical device trials, drug trials, investigator-initiated s...

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USD 40/hr
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Cristal R.

Medical doctor with 5+ years of clinical research, medical writing and biostatistical analysis experience.
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USD 25/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...

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USD 25/hr
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Yasir K.

Academic Research Writing ; Literature Reviews ; Meta-analysis ; Technical Writing ; Medical Writing ; Systematic Review
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USD 13/hr
Masters in International Relations
United States

With over 8 years of technical content writing experience in a broad range of domains, I am a highly experienced Content Writer. My role involv...

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USD 13/hr
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Dr. JORDANA S.

Ph.D. student in pharmaceutical sciences ǀ Pre-clinical/Clinical studies ǀ Innovation ǀ Entrepreneurship ǀ Biotech
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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...

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USD 10/hr
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Dr. Angela P.

Expert Biomedical Scientist and Scientific Editor and Writer
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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...

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USD 70/hr
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Dr. Adam E.

Freelance drug and medical device Regulatory Affairs consultant | Expert in preclinical and clinical trial design
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USD 100/hr
Doctorate of Philosophy (PhD)
Australia

My research interests are in the design, development and assessment of novel drugs to prevent brain injury in infants and adults.

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USD 100/hr
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Dr. Natalie B.

Clinical researcher (PhD in Pharmacology) with 12 years’ experience spanning academia, Government and the private sector
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USD 75/hr
PhD - Experimental Pharmacology
Australia

• Solid knowledge of Good Clinical Practice guidelines, Medical Code of Conduct and local clinical trial regulatory requirements. • Medical an...

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USD 75/hr
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Dr. Javier G.

Experienced Medical Doctor and Freelance Medical Writer | Harvard-trained Researcher and Manuscript Writer
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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...

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USD 150/hr
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Dr. Daniel P.

Freelance Market Access Consultant for Pharmaceutical products (CH, A)
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USD 150/hr
Dr. med.
Croatia

Trained Physician with clinical and 10+ years of practical experience in Market Access and Life Cycle Management of pharmaceutical products in ...

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USD 150/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.