Hire a Freelance Regulatory Writer: Find an FDA Submission Expert

Khushbu P.

Regulatory affairs (eCTD submission) with 3+ years of experience. Working as freelancer for PharmaLex (PDE compilation)
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USD 11/hr
Master of pharmacy (Pharmacology)
India

I am Khushbu Pitroda, completed masters in pharmacy (Pharmacology) in 2015, Bachelor of pharmacy in 2013 and Diploma in pharmacy in 2010 from G...

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USD 11/hr
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Poornima M.

Scientific and medical writer with 11+ years clinical writing experience
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USD 30/hr
Master in Pharmacy
India

I am a Masters in Pharmacy specialising in pharmaceutics and drug formulation science from Rajiv Gandhi University of Health Sciences, Bangalor...

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USD 30/hr
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Shiva L.

Regulatory Medical writer with 6.5 years if experience
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USD 60/hr
Molecular Genetics and Molecular Biology
India

Preparation of CER,PER, SSCP, PSURs, PMS Performing Literature search in Literature databases Hands on experience on Literature referencing to...

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USD 60/hr
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Mike K.

FDA Regulatory Consultant
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USD 150/hr
Bachelor of chemistry and Biochemistry
United States

Mr. Khalil’s professional career spans over thirty (30) years of executive and entrepreneurial leadership in pharmaceutical, medical devices, n...

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USD 150/hr
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Tarun P.

Regulatory Expert (Consultant) having 25 years of experience working with Pharma, CRO and Medical Device Industry
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USD 150/hr
MBA
India

Vision-driven executive with over 25 years of demonstrated leadership in the pharmaceuticals industry. Proven track record of driving bold init...

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USD 150/hr
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Tarana S.

Experienced Bioanalytical Scientist with extensive expertise in Analytical Chemistry, Scientific Writing and Research.
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USD 60/hr
M.Sc. Biochemistry and Molecular Biology, Horticulture and Agronomy
United States

I am a Bioanalytical Scientist with over 15 years of experience in the pharma and biotech industry and extensive expertise in Analytical Chemis...

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USD 60/hr
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Gaurav P.

Biomedical Sciences | Inflammation and oxidative stress cell biology | Electrochemical Biosensor | Data Analytics |
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USD 27/hr

Passionate researcher in disseminating the different domain knowledge for interdisciplinary and real-time application through persistent effort...

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USD 27/hr
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Surya N.

CMC Expert with 20+ years of Regulatory and Formulation experience for USFDA, EMEA, Japan, Canada and ROW Markets
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USD 90/hr
M.Pharm.
India

SME (Subject Master Expert) in the Regulatory Affairs and Compliance Development of Finished Formulations (OSD and Injectable) Scientific Advi...

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USD 90/hr
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Jose A.

Freelance Medical Device professional with over 25 years of experience implementing QMS systems and RA compliance
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USD 175/hr
M.S Clinical Nutrition
United States

Behind every successful medical device registration, there is a team of experts working hard to ensure it meets regulatory requirements. As a Q...

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USD 175/hr
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Raju B.

Regulatory Toxicologist, Scientific medical writing, Study director
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USD 15/hr
Regulatory Toxicology
India

Experienced toxicologist in risk assessment in various chemicals, ingredients, extractable and leachable and medical devices as per ISO, PDE, O...

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USD 15/hr
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SUCHANDRIMA B.

Research Enthusiast| Medical Writer| Editor
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USD 20/hr
M.Sc. Microbiology
India

I am a Research Enthusiast trying to blend my love for writing and research into medical writing. I have experience in Content Writing and Acad...

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USD 20/hr
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Linda R.

Certified Food Scientist. MS in Food Microbiology. Project/Program Manager. 15+ years experience in the food industry.
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USD 50/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...

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USD 50/hr
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Peter O.

Experienced quality assurance and regulatory affairs professional in the medical device industry.
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USD 300/hr
MS Engineering Management
United States

Product experience includes Class 1, 2 and 3 devices: external defibrillators, AEDs, infusion pumps, patient monitors, image guidance, ventilat...

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USD 300/hr
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Ana Sofia C.

English to Portuguese Medical Translator and Writer with 15 years of experience
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USD 70/hr
Specialization Course in Translation - English
Portugal

I am an English to Portuguese Medical Translator and Writer working with Life Sciences companies, Contract Research Organizations, Language Ser...

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USD 70/hr
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devi s.

Freelance medical writer|Expert in regulatory and safety|Medical writer with 8+ years of experience in Pharmacovigilance
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USD 25/hr
M.Pharm
India

Experienced in regulatory writing, scientific writing and medical affairs in key therapeutic areas.Literature monitoring, Documents worked on i...

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USD 25/hr
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Ashwini L.

Quality Management System, Risk Assessment, Post Market Surveillance, Lead Auditor ISO 13485, Compliance Expert
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USD 70/hr
Bachelors
Netherlands

Over 15 years of experience in Quality and Regulatory Affairs, Risk Assessment, Verification, and Validation, of medical devices like Patient M...

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USD 70/hr
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BS
United States
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USD 75/hr

Motivated, self-driven entrepreneur, consultant to regulatory affairs and QC/writing departments within the medical, biotech and pharmaceutica...

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USD 75/hr
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Mariangela M.

Medical Writer, Science Communication, PhD in Experimental and Molecular Oncology
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USD 15/hr
Specializzation in Food Science
Italy

Deep experiece in molecular oncology, NGS, Clinical Research and data management. Autonomy, flexibility, organization and interpersonal skills.

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USD 15/hr
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Anupam M.

Clinical research postgraduate with more than 11 years of experience in Medical Writing & regulatory submission
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USD 20/hr
Bachelors, Chemistry
India

Experience summary:  Author and review regulatory periodic safety reports (Periodic Benefit-Risk Evaluation Reports Developmental Safety Updat...

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USD 20/hr
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Rob F.

Quality System and Regulatory professional with over 20 years of experience
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USD 75/hr
Bachelor of Science in Applied Arts and Sciences Biology
United States

Rob is a Quality System and Regulatory professional with over 20 years of experience in QMS development, deployment, and remediation in the med...

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USD 75/hr
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Reema D.

14 years of experience in CMC author, Post-Approval Changes, Query Responses, XEVMPD
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USD 50/hr
MBA
India

• Preparation of CTD sections of the dossiers required for Regulatory submission in various countries namely EU (National, MRP and DCP), US (AN...

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USD 50/hr
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A D.

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USD 12/hr
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USD 12/hr
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Viky Gilles Daniel V.

Global Regulatory Affairs Consultant - FDA - Medical Device - Pharma
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USD 150/hr
Global Regulatory Affairs Certification
United States

Guru providing regulatory affairs services to the medical device / medtech, biotech, and pharmaceutical industries. Qualification supported by ...

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USD 150/hr
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Prerana D.

Clinical research professional having an extensive knowledge on medical devices CE marking and consulting services.
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USD 10/hr
M.Sc Clinical Research
India

A clinical research post-graduate having a vast knowledge over a range of Medical devices consulting services on conformation of 62304:2006 sta...

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USD 10/hr
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Natasha L.

Industry Researcher | Oncology | Immunology | Microbiology | Academic Writing | Manuscript Writing | Creative Writing
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USD 62/hr
Masters of Science in Cellular and Molecular Oncology
United States

I am currently a cancer researcher at a large pharmaceutical company. My primary scientific background is biology, and I am highly specialized ...

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USD 62/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.