Hire a Freelance Regulatory Writer: Find an FDA Submission Expert

Portfolio Management Professional
United States
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Executive Management |Project, Program, Portfolio Management - PMO ~ Robotics |Biotech | Pharma | Medical Devices | FDA I develop and delive...

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Dr. Ntube Olive N.

Toxicologist with 13+ years of experience in scientific research, technical report writing, peer literature review
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Ph.D. Pharmacology and Toxicology
United States

* Experience in conceiving, planning, designing, executing, and troubleshooting toxicology studies using various molecular biology, biochemistr...

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Dr. Michelle M.

Board Member | Consultant | Advisor | Interim Leadership ✰ Regulatory Affairs ✰ Compliance & Ethics ✰ Quality Assura...
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Doctoral Program
United States

✰ Open to Work ✰ Available for Short & Long Term Engagements ✰ ✰ Available for due diligence, consulting, advisory, leadership and boa...

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Dr. Neeti S.

Ph.D. Biotechnology, Experienced Research Professional.
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PhD Biotechnology
Germany

Ph.D. in Biotechnology with a biochemistry background and 6+ years of extensive research experience in academia. Microbiology, agriculture, pl...

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Dr. Daniel P.

Freelance Market Access Consultant for Pharmaceutical products (CH, A)
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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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Dr. Nadeem A.

Cell and Molecular Biologist | MBA in Medical devices and Healthcare Management | Certified in Regulatory Affairs - GxP
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The London School of Economics and Political Science (LSE)
Germany

• Cell biologist with seven years of academic scientific writing experience • MBA candidate in Medical Devices and Healthcare Management with t...

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USD 80/hr
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Dr. David M.

Senior Medical Writer | QPPV | Medical Device Regulatory Expert | Pharmacovigilance Consultant |
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USD 100/hr
Medical Degree (MD)
Hungary

✔ Pharmacovigilance Physician, Medical Regulatory Writer, LQPPV, Project Manager, Clinical Trials Regulatory Expert. ✔13+ years professional me...

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Dr. Nitesh D.

An experienced Biopharma professional in business of Biopharmaceutical product Development in US, EU and Emerging mkt
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PhD
India

I am an experienced Biopharma program director in business of Biopharmaceutical products. I have grown up the value chain by living through the...

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Dr. Agnese B.

Animal Scientist, Science Outreach and Project Manager
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PhD
United Kingdom

I have nine years of experience in the field of animal science encompassing academic research, public health and regulatory institutes. I am a ...

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P.h.D. Analytical Chemistry
India
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I lead and support drug development and production for clinical development and commercial products. I have two years working experience in pha...

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Dr. Wing C.

Medical scientisit experted in regulatory/scientific writing and depicting clinical/business landscape of biotech
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PhD
Taiwan

Wing Chuang is specialized in clinical trial protocol development, in compliance with local regulatory requirement, in co-operation with toxico...

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Dr. Maria O.

Regulatory Writing and Technical Content
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PhD Biological Scinces
Switzerland

Formerly RA Manager at ETH Zurich

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Dr. Alicja S.

Science | Innovation | Investment
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PhD, Biochemistry and Molecular Biology
Italy

Ala Santos has 15+ years of multidisciplinary experience spanning cancer and cardiomyopathies research. On the top of the technical expertise, ...

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Dr. Evita A.

Medical Writer/Regulatory Affairs/Project Manager
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USD 210/hr
Masters degree in Biomedical Science
United States

A clinical research scientific writer with clinical medical, CSR. and regulatory CER expertise in MEDDEV 2.7/1 rev4 documentation, EU MDR and F...

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Dr. Damien T.

Freelance scientific expert specialized in preclinical development - technical writer
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PhD
France

Scientist executive (PhD) and entrepreneur with extensive experience in biotech R&D. Deep technical and scientific expertise (15+ years) in...

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Dr. Harsh V.

Medical/Scientific/Regulatory/Newsletter/CMC/Dossier/Research/Review/Thesis/Protocol/Report/Article writing & editin...
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PhD
India

A competent pharma professional with experience in Scientific writing, Regulatory competitive intelligence, DRA, F&D, MSAT and QA. Experie...

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PhD
United States
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-Biomedical scientist with over 5 years of research experience and a strong background in a wide range of research areas such as Oncology, Mole...

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Dr. Bharat K.

Formulation Development, Validation, and Tech Transfer Professional. 15-years combined industrial & academic experie...
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Pharmaceutical Sciences, Industrial Pharmacy
United States

Quality by design: Build quality into drug product from early development Extended release: Formulation of tablets, capsules, and suspensions f...

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Dr. Shripad N.

Analytical, Quality & Regulatory Expert in Pharmaceuticals
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PhD (Chemistry)
India

30 plus years of experience in analytical development, Quality, and Regulatory submission in drug substances and drug product

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Dr. Cynthia D.

Freelance medical and scientific writer with an expertise in biotechnologies, molecular biology and rare diseases.
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Doctorate
France

Freelance Medical and Scientific Writer with 4+ years experience in scientific writing Science Blog Writer and Editor (biologicallycurious.com)...

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Courtney W.

Writer/ Health Research /Community Health Professional
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Masters of Science
United States

M.S. Health Science (Health Administration- Community Health Education and Promotion); 20+ years of human subject (clinical...trials) and community-based participatory research (behavioral; violence prevention, senior health; public...

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Bryan M.

Data analyst, writer, and editor with 10+ years' experience and over 50 publications in multiple
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Bachelors
United States

• Statistics and Data Analysis. • Experimental Design • Scientific and medical writer and editor. • Scientific Illustrator • Project Manage.... • Selected publications: https://www.ncbi.nlm.nih.gov/myncbi/browse/collection/xxxxxxxx/?...

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Alexander B.

Early Phase Oncology, Expert in Trial Management, Client Relations, Site Relations, 12 years experience
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BS - Molecular Biology
United States

I have 12 years experience, starting as a Lead Coordinator at a clinical research site. Worked in the CRO space in study start-up, as a CRA, Cl...

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Syed Mohsin A.

Medical writer with 6+ years of experience in clinical research & SPSS expert
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Bachelors, Chemistry
United Kingdom

This is Mohsin, I am a professional Freelancer having extraordinary skills in writing, Marketing & graphic designing. Having 6+ years of ex...

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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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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.