Hire a Freelance Regulatory Writer: Find an FDA Submission Expert

Dr. Thatiana Evilen d.

Freelance Scientific Consultant | Expert in Molecular Biology | Geneticist with 10 years of experience
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USD 40/hr
Speed Woman Mentoring
Brazil

Graduated in Biological Sciences (Bachelor's degree) at São Camilo University Center (2008). Science Master’s degree (2012) and Ph.D. ...

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USD 40/hr
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Dr. Oyinkansola S.

Medical Doctor and Writer: Bridging Knowledge and Communication in Healthcare
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USD 40/hr
MPH
United Kingdom

Overview: As a dedicated Medical Doctor and accomplished Research Writer, I bring a unique blend of medical expertise and writing proficiency ...

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USD 40/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. 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. Sanjaya C.

Clinical Researcher/Medical Writer/Statistician with 7+ years of experience in health care industry
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USD 30/hr
MSc Medical Statistics
Nepal

I am a pro-active person trained in clinical pharmacology and biostatistics. Currently, I'm leveraging my clinician skills in the improveme...

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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. Murtaza Najabat A.

Medical Device Development | Healthcare Technology Specialist | Regulatory Affairs Specialist
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USD 80/hr
PhD in Materials Science
Pakistan

I am a biomedical engineer with over 20 years of experience in medical device development and healthcare technology. Apart from academia, I hav...

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USD 80/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. Cameron R.

Doctor of Analytical Chemistry, Expert in NMR spectroscopy applications for Industry.
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USD 30/hr
PhD Analytical Chemistry
United Kingdom

Currently working with multiple industry partners to incorporate NMR spectroscopy into their work flows. Partnerships are with consumer health,...

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USD 30/hr
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Dr. Ana Carolina E.

PhD in Neuroinflammation from UCL, independent biomedical researcher, medical software and clinical trials.
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USD 50/hr
PhD in Ophthalmology (Neuroinflammation)
United Kingdom

PhD graduate with 6+ years of biomedical research experience in immunology, vascular biology and auto-immune diseases. Experience in phase III/...

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USD 50/hr
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Dr. Joyita B.

Creator & Content developer of Materials Data Explorer (https://bjoyita.github.io)/ | Materials Scientist
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USD 20/hr
PhD (Materials Science & Engineering)
India

I am a materials scientist. I earned my masters and doctorate degree in materials science and engineering from the Indian Institute of Science,...

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USD 20/hr
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Dr. Paula d.

Health Care, Regulatory Affairs & Safety Consultant
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USD 150/hr
BS- Nursing
United States

More than 17 years working as Health Care Consultant for different companies and agencies, as well as a professor from a private and public un...

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USD 150/hr
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Dr. Geetanjali B.

Research Scientist with experience in Medical Devices, Pre-clinical Research and Writing
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USD 50/hr
PhD
United States

I am a Ph.D. in Bioengineering with expertise in medical device development and innovation, experimental design, data analysis and interpretati...

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USD 50/hr
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Dr. Onkar S.

Medical Writer, Reviewer & Physician| Expert in Drug Development, Medical Affairs, Clinical Research, Regulatory &am...
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USD 30/hr
MD Pharmacology
India

Medical Doctor & academician turned into pharmaceutical professional. +15 years of experience with leadership positions in drug develop...

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USD 30/hr
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Ph.D. - Biochemistry and Molecular Biology
India
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USD 50/hr

Global professional, doctoral-level research experience in life sciences. Experienced in scientific writing, ICH-GCP E6 framework, clinical res...

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USD 50/hr
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Dr. Pharmanalytics S.

Freelance in pharma domain having specialization in generic market and expertise in the analytical and regulatory,
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USD 30/hr
Doctors in Analytical chemistry
India

Having an experience of more than 15 years in the analytical and regulatory domain with sound technical understanding to fulfill different regu...

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USD 30/hr
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Dr. Girish D.

Medical writer with 14 years experience in regulatory writing, scientific writing, safety writing.
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USD 30/hr
Ph.D.
India

Prepare and review clinical and scientific documents that are part of regulatory submission including Clicical Study protocols, Clinical Study ...

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USD 30/hr
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Dr. Gabriella G.

Clinical Protocol Writer, Clinical research professional, GCP and CCRP Certified, Scientific writer, Grant proposal
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USD 90/hr
PhD
United States

Goal-oriented biomedical research with more than 10 years experience and demonstrated achievement in managing clinical/translational research p...

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USD 90/hr
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Dr. Aissulu I.

Master of Medicine, Medical Doctor, the Lecturer at the Medical University with a deep experience in Clinical trial
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USD 100/hr
master of medicine
Kazakhstan

CT: oncology, infections, gastro, gynecology, diabetis

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USD 100/hr
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Dr. Pierre L.

Healthcare technology development, 20 years engineering excellence + quality assurance & regulations navigation
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USD 155/hr
PhD industrial Engineering
Australia

If you are an entrepreneur/founder in health-tech, I can help you * fine tune your strategy * navigate science, engineering, quality processes ...

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USD 155/hr
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Dr. Dayene C.

PhD and Masters in Biological Science (Respiratory Physiology). Background in Clinical Trials and Science Writing.
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USD 30/hr
PhD Visiting Researcher
Brazil

Experience with: Clinical Trials Phase I-IV, Lung Therapy and Toxicology, Respiratory Disease (including COVID-19), Cell Therapy (Stem Cells), ...

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USD 30/hr
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Dr. Waqar L.

Auditing, Consulting, Training and Operations Management for International Standards i.e. ISO, BSCI, DIN, MDD, MDR, PPE
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USD 75/hr
PhD
Pakistan

Ten + years of hands-on technical working experience in the manufacturing environment covering Metal, Textiles, Food, Auto parts, Chemical proc...

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USD 75/hr
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Dr. Sam M.

Certified and experienced professional medical/scientific writer with 18 years of experience
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USD 30/hr
Doctor of Philosophy (Ph.D, Pharmaceutical sciences)
India

I am a Doctorate (PhD) in Pharmacy, a Certified Medical Publication Professional™ (CMPP), a certified Information Mapping Professional™ (IMP) a...

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USD 30/hr
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Dr. Codette P.

One stop solution for end to end Life Sciences global Regulatory support.
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USD 50/hr
PhD
India

Codette Pharma Regulatory Analytics Pvt Ltd provides top-level global regulatory and clinical support to Life Science companies. We are experts...

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USD 50/hr
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Dr. Sarika P.

The RAC qualified Regulatory Professional with more than 20 years of experience in the global regulatory submissions.
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USD 150/hr
Ph.D
India

The RAC-qualified Pharma Professional with more than 19 years of experience in regulatory, PV, and clinical research. Hold expertise in global ...

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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.