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Hire a Regulatory Writing Expert

Joanabel Adorino

Food Technologist/ Freelance Content Writer
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$10.00/hr
BS in Food Technology
Philippines

I help Food Scientists on their business or projects related to Quality Assurance, Regulatory and Technical Writing.

$10.00/hr
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Dr. Bishnupriya Bhattacharya

Virologist and clinical trial specialist with 10+ years experience in basic science and clinical research
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$45.00/hr
PhD
United Kingdom

• Broad research and knowledge base in virology, molecular biology, drug target discovery, vaccine development, bioinformatics, antibody develo...

$45.00/hr
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Alifiya Tahir

Clinical Research Scientist & Medical Writer with 5+ years of experience in academia & pharmaceutical industry
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$10.00/hr
Master of Public Health (Epidemiology & Biostatistics)
United States

I am a research scientist/medical writer trained in clinical sciences, epidemiology and biostatistics (BDS, MPH, Rutgers University, USA). My p...

$10.00/hr
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Loughlin Gethins

Microbiologist | SME in BioTechnology, Fermentation, High Throughput, Flavours, Regulatory Testing and Yeast Genetics
Microbiology (MSc.)
United Kingdom

I studied Microbology (H. BSc) in University College Cork (U.C.C) where I wrote a review article on the Applications of Phage Therapy as an alt...

PhD
United States
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$40.00/hr

My pre-doctoral, doctoral and post-doctoral training collectively focused on cell and molecular biology approaches to dissect mechanisms of dev...

$40.00/hr
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Dr. Jasmien Roosenboom

PhD and postdoctoral experience in craniofacial genetics, experience as commercial translation consultant
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$75.00/hr
PhD
United States

Experience in craniofacial genetics, medical imaging on postdoctoral level. Experience in market research, intellectual property landscape and ...

$75.00/hr
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Dr. Peter Kovacs

Medical and Scientific Expert with 20 years’ experience in basic-, preclinical and clinical research and medical affairs
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$40.00/hr
Postdoctoral research program in Behavioral Neuroscience
Hungary

Medical and scientific writing and advising. Special interest in neurosciences, drug research and new drug discovery. Highly advanced presentat...

$40.00/hr
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Bharti Sharma

Freelance medical writer, COVID-19 virologist, Coronavirus expert, CER writer, MDR Consultant, Scientist, clinical trial
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$90.00/hr
Master of Public Health (M.P.H.), Introduction to Systematic Review and Meta-Analysis
India

A strong background in viorology, medical microbiology and public health qualifies me to work on COVID-19 projects (factsheets, COVID-19 at hom...

$90.00/hr
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Dr. Onkar Swami

Medical Writer, Reviewer & Physician| Expert in Drug Development, Medical Affairs, Clinical Research, Regulatory &am...
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$30.00/hr
MD Pharmacology
India

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

$30.00/hr
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Ph.D. - Biochemistry and Molecular Biology
India
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$50.00/hr

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

$50.00/hr
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Dr. Loren DeVito

Medical writer/consultant
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$85.00/hr
MA, PhD
United States

Loren DeVito, PhD, is a science and medical writer with expertise across a wide range of therapeutic areas, including oncology, neurology, card...

$85.00/hr
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Dr. Girish Deshmukh

Medical writer with 14 years experience in regulatory writing, scientific writing, safety writing.
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$30.00/hr
Ph.D.
India

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

$30.00/hr
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Dr. Mrudul Vekaria

Experienced medical writer/ MDR consultant
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$25.00/hr
Master of pharmacy
India

I am medical writer with more than 5 years of experience in writing regulatory and clinical research document. My expertise is development of c...

$25.00/hr
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Dr. Waqar Latif Butt

Auditing, Consulting, Training and Operations Management for International Standards i.e. ISO, BSCI, DIN, MDD, MDR, PPE
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$75.00/hr
PhD
Pakistan

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

$75.00/hr
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Dr. Randall Smith Jr., PhD

Biomedical Scientist, Writer and Editor, Life Sciences Consultant
PhD Biomedical Engineering
United States

I am an ambitious and published scientist who is experienced in many scientific disciplines including Biology, Chemistry, and Engineering. I ha...

I am a trained medical and regulatory writer, experienced and specialized in Precision Medicine Oncology. I also have expertise in Neuroscienc...

Dr. Ankur Patel

Experienced CER Writer
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$85.00/hr
Master of Science
United States

My expertise is development of clinical evaluation reports (CERs). This includes experience with literature searches, post-market surveillance,...

$85.00/hr
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• Staff Research Associate - UCSD Shiley Eye Institute (Current): Project focusing on understanding retinal ischemic diseases, specifically the...

Dr. Dr. Kritee Pant

Pharmaceutical development Project Manager & Senior Research Scientist at ROTOP I Cancer Diagnosis & Therapy
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$30.00/hr
PhD Chemistry (Molecular diagnostics for Cancer research; summa cum laude)
Germany

I am a scientist with more than 9 years of experience in the field of chemistry for healthcare applications esp. on cancer research using molec...

$30.00/hr
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Dr. Yee-Shuan Lee

Scientist with 10+ years of experience in basic, pre-clinical, and clinical research
PhD
United States

My basic research experience is in tissue engineering in the neural application. I have experience in both in vitro and in vivo experiment desi...

Portfolio Management Professional
United States
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$150.00/hr

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

$150.00/hr
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Dr. Adam Schindler

Experienced medical and scientific writer with experience in clinical and regulatory documents.
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$100.00/hr
PhD
United States

Experienced medical writer with expertise in clinical writing (clinical trial protocols, study reports, IBs, ICFs) and regulatory writing (IND,...

$100.00/hr
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P.h.D. Analytical Chemistry
India

I lead and support drug development and production for clinical development and commercial products. I have two years working experience in pha...

Dr. Sudhansu Sekhar Swain

Pharma Analytical Scientist, twelve years of experience in analytical research and regulatory responses i.e. FDA, EU etc
PhD in Pharmacy
India

I have twelve years of experience in pharmaceutical analytical research. My core expertise is analytical method development by various techniqu...

Dr. Evita Asumugha

CER Medical Writer/Associate Project Manager
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$110.00/hr
Masters degree in Biomedical Science
United States

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

$110.00/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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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