Hire a Freelance Regulatory Writer: Find an FDA Submission Expert

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. 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. 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. 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. 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. 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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Dr. Nitin M.

Scientific Advisor at Melior Life Sciences (CRO) | Consultant Radiologist | AI Research Advisor at Synapsica |
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USD 125/hr
MD
India

After completing MBBS from the All India Institute of Medical Sciences, New Delhi. He pursued MD in Radiodiagnosis from SMS Medical College and...

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USD 125/hr
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Dr. Precious O.

Freelance Medical Writer with 5 year experience in Biomedical/Clinical Research
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USD 25/hr
Medical Degree (MD)
Nigeria

I am experienced in

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USD 25/hr
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Dr. Sheraz Hussain S.

Medical device regulations EU MDR 2017/745,Clinical evaluation ,ISO 13485 AND validation expert
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USD 335/hr
Doctor in Dental Sciences
Pakistan

1.Preparation of Clinical Evaluation Reports (CERs) in accordance with Medical Device Regulation (MDR) and 93/42/EEC Medical Device Directive (...

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USD 335/hr
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Dr. Sudhansu Sekhar S.

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

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

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Dr. John N.

Medical Writer for Academic Publications, Grant Applications and Regulatory Affairs | 10 years | [NOT
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USD 19/hr
Statistics for Medical Professionals
Australia

[NOT AVAIL ATM] Medical Writer and Grant Writer for 10 years across innovation-intensive research organisations in Australia including the St V...

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USD 19/hr
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Dr. Randall S.

Biomedical Scientist, Writer and Editor, Life Sciences Consultant
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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...

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Dr. Swarupa S.

Ideation, Conceptualization, Design and developing Supplier Network for various premium functional cosmetics. Ideation,
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USD 40/hr
PhD (Environmental Science)
India

Knowledge on Traditional Indian Medicine (TIM) is my core strength. Back to nature is my theme. I strongly believe that the answers to all the ...

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USD 40/hr
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Dr. Dr. Kritee P.

Pharmaceutical development Project Manager & Senior Research Scientist at ROTOP I Cancer Diagnosis & Therapy
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USD 30/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...

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USD 30/hr
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Dr. Alpa B.

Medical writer with 8+ years of experience in writing CEPs, CERs, PMSRs and SSCP for Class II Medical Devices
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USD 30/hr
Bachelor of Dental Surgery
India

I am Dr. Alpa Ben, a BDS graduate from India. I have been working with healthcare service industry from past 8 years and have experience in var...

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USD 30/hr
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PhD
United States
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I am a trained medical and regulatory writer, experienced and specialized in Precision Medicine Oncology. I also have expertise in Neuroscienc...

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Dr. Ankur P.

Experienced CER Writer
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USD 85/hr
Master of Science
United States

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

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USD 85/hr
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Dr. Gabriela L.

Medical writer | Scientific consultant | Biostatistics analyst
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USD 25/hr
MSc in Pharmacology
Brazil

I have a master's and a doctorate in Pharmacology, a post-bachelor degree in Regulatory Affairs and a bachelor's degree in Pharmacy. I ...

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USD 25/hr
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M.D.
United States
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• Staff Research Associate - UCSD Shiley Eye Institute (Current): Project focusing on understanding retinal ischemic diseases, specifically the...

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Dr. Jessica L.

Scientist with 10+ years of experience in basic, pre-clinical, and clinical research
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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...

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Dr. Wen Chean L.

Medical Writer/ Life Sciences and Healthcare Consultant, 10+ years research experience in Immunology and Oncology
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USD 50/hr
PhD in Infection, Inflammation and Immunity
Australia

I have a strong background in immunology and oncology, with over 10 years of research experience across academia and biotech/pharma. I possess ...

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USD 50/hr
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Dr. Maicel M.

I am a medical doctor and researcher in the field of clinical trials, epidemiological research and data science.
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USD 50/hr
Biostatistics specialist
Cuba

I have experience in the preparation of analysis plan and statistical processing report. I perform statistical processing in R, SPSS, Python, E...

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USD 50/hr
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Dr. Leticia M.

Freelance Writer, Consultant, Translator | Biopharmaceutical industry, cosmetics, scientific and regulatory writing.
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MBA in cosmetic development and marketing
Ireland

I am a pharmacist with a PhD in chemical and bioprocess engineering, working as a bioprocess scientist. I have experience with cell culture, up...

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Dr. Rony C.

Grant and proposal writer / Project Manager
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USD 40/hr
PhD
Canada

I have developed the required expertise to lead several ongoing projects simultaneously in an efficient manner while maintaining meticulous att...

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USD 40/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.