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Dr. Julia Jenkins

PhD in Biochemistry and Medical Writer with 20+ years of experience
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$50.00/hr
PhD
United States

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

$50.00/hr
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Dr. Ana Luiza Cassin Duz

Freelance Medical writer, Clinical specialist and Regulatory affairs of Medical Devices, Ph.D. Biological Sciences
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$50.00/hr
MBA Quality Management
Brazil

I have over 8 years of experience in Clinical Research, Regulatory Affairs and Quality Assurance of implantable and electro medical devices in ...

$50.00/hr
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PhD
United States
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$100.00/hr

Industry leader with 20+ years of expertise in the clinical trial, drug development space. PhD Biotech, Adv Dip French Literature. Have represe...

$100.00/hr
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Dr. VANOJAN MANICKANADARAJAH

Medical Writer and Editor
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$50.00/hr
MD (Doctor of Medicine)
Sri Lanka

I am a medical doctor and a medical writer for the past 5 years. I have worked with many researchers, surgeons, dermatologists, nephrologists, ...

$50.00/hr
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Dr. Shrinidh Joshi

PhD in Pharmaceutical Science with 11+ years of experience in Pharmaceutical - Clinical - Regulatory- Medical writing
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$70.00/hr
Doctor of Philosophy (PhD)
Canada

I am an agile, performance-driven and critical problem solver scientist with a passion for scientific consulting, disseminating strategic, stre...

$70.00/hr
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Dr. Sanet Aspinall

Experienced clinical research and health consultant providing consulting, training and medical writing.
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$100.00/hr
Certificate in Leadership & Performance Management
South Africa

I provide clinical research and health consulting, medical writing and training services to Pharma, Biotechnology Companies, CROs, NGOs, Founda...

$100.00/hr
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Dr. Katrina A. Bramstedt, PhD

Bioethicist, Research Ethicist, IRB/REC Expert
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$150.00/hr
PhD Community Medicine
United States

I have reviewed 2000+ research protocols and helped created hundreds of consent forms for complex research studies. I'm an expert with the...

$150.00/hr
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Dr. Neha Pawar

Medical Writer Teach For Free
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$12.00/hr
Ph.D (Pharmacology)
India

Neha Pawar, with a basic pharmacy degree (pharmacist) is specialized in Pharmacology (Masters and Ph.D.) from renowned institutes, is a success...

$12.00/hr
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Dr. Conor Sheehy, PharmD, BCPS

Medical Writer | Clinical Pharmacist
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$80.00/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...

$80.00/hr
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Dr. Stuart Cantor

Scientist/Consultant w/R&D & Manufacturing Expertise in Pharmaceutical/Nutraceutical/Food/Cannabis Industries
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$90.00/hr
Ph.D. Pharmaceutical Sciences
United States

Pharmaceutical/Nutraceutical/Food Formulation Scientist with 20+ years of experience developing soft chews, tablet and capsule products, chewab...

$90.00/hr
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Adam Freeman

exFDA Investigator / expert in Medical Device & Combination Product design, manufacturing, and compliance
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$200.00/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...

$200.00/hr
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Dr. HARSHIT SHAH

Research Scientist | Clinical Trial Consultant | Oncology | Pharmacology | Biotechnology | Freelance Scientific Writer
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$50.00/hr
Masters in Pharmacy (Pharmacology)
United States

I am an experienced health professional, having 6+ years of thorough working experience in clinical research and the therapeutic research indus...

$50.00/hr
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Dr. Sonika Verma

Medical Writer and researcher having 10 years of post qualification experience in clinical and epidemiological research.
Diploma in Applied Epidemiology
India

Experienced Medical Writer with a demonstrated history of working in the pharmaceutical industry and research organisations of international re...

Dr. Mathew Weisman

Life Sciences Consultant, Writer, and Editor
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$60.00/hr
PhD in Biochemistry
Israel

I am a PhD enzymologist and protein biochemist with over 30 years experience in the biopharma and industrial biotechnology sectors, including 1...

$60.00/hr
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Dr. Paula de Sa

Health Care, Regulatory Affairs & Safety Consultant
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$150.00/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...

$150.00/hr
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Dr. Sam Mathew

Certified and experienced professional medical/scientific writer with 18 years of experience
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$30.00/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...

$30.00/hr
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Dr. Wing Chuang

Medical scientisit experted in regulatory/scientific writing and depicting clinical/business landscape of biotech
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$90.00/hr
PhD
Taiwan

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

$90.00/hr
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Dr. Codette Pharma Regulatory Analytics Pvt Ltd

One stop solution for end to end Life Sciences global Regulatory support.
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$50.00/hr
PhD
India

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

$50.00/hr
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Dr. Mary Ritchey

Experienced real-world researcher, generating evidence from clinical data for medical devices and pharmaceuticals.
PhD, Epidemiology
United States

Mary Beth Ritchey, PhD, FISPE has spent more than 15 years in government, industry, consulting, and academia in better understanding medical pr...

Dr. Dr. Sarika Pardhe

The RAC qualified Regulatory Professional with more than 17 years of experience in the global regulatory submissions.
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$150.00/hr
Ph.D
India

 The RAC qualified Regulatory Professional with more than 17 years of experience. Hold expertise in the global regulatory submissions, approva...

$150.00/hr
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Nida Ali

Experienced MDD and MDR certified CER/Technical File Writer with 5+ years of experience with multinational industries
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$50.00/hr
Bsc in Biomedical Engineering
Pakistan

An experienced clinical research and medical device Technical file writer who has certified on MEDDEV 2.7/1 Rev#4 documentation, EU MDR, ISO-10...

$50.00/hr
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SAFETY ASSESSMENT OF COSMETICS IN THE EU
United Kingdom
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$30.00/hr

Registered UK and EU Toxicologist. Experienced in EU cosmetic regulations. Skills: Cosmetic Product Safety Reports (CPSRs) Toxicological revie...

$30.00/hr
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K Latha

Doctor with 15+ years of experience in clinical research
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$100.00/hr
MD
India

Am a physician with more than 15 years of experience in the field of Clinical Research having expertise in Clinical trials, Medical review, Med...

$100.00/hr
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Linda Rosenberg Minkow, CFS

Certified Food Scientist. MS in Food Microbiology. Project/Program Manager. 15+ years experience in the food industry.
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$50.00/hr
MS
United States

My name is Linda Minkow. I'm a food scientist with a Masters in Food Microbiology from Rutgers University. I have over 15 years of experien...

$50.00/hr
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Arjun Lakshmana Balaji

Physician | Clinical & Medical Affairs | CER | Scientific Writing | Pharma labeling | Strategy | HealthTech | Resear...
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$30.00/hr
Masters of Public Health (Epidemiology, Clinical Infectious Diseases and Global Health Majors)
India

I have a blend of experience in clinical medicine, pharmaceutical industry and medical device industry. As a medical doctor, I work on infectio...

$30.00/hr
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Hire top freelance regulatory writers for help with technical documents, regulatory compliance, and more. Post your project securely and get quotes for free. Kolabtree is the world's largest platform for hiring trusted freelance scientists and consultants on demand.

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Kolabtree ensures safety and security of your payments and personal information and project details. Kolabtree’s T&C includes a default confidentiality clause. You can also sign NDAs and custom agreements with freelancers for additional protection.

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How to hire an expert in regulatory writing

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.

Related skills

Clinical Research          Clinical Trials          Drug Development           FDA Submissions          Medical Device                                                                                                                           Medical Sciences          Medical Writing          Pharmaceutical Industry           Product Development           Regulatory Writing           Technical Writing