Hire Freelance Regulatory Writers: Find an FDA Submission Expert

Certificate in Leadership & Performance Management
South Africa
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USD 100/hr

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

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USD 100/hr
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PhD
United States
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USD 100/hr

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

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USD 100/hr
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Master in Pharmacology
United Arab Emirates
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USD 40/hr

Clinical Project Management and Medical Writing professional with 11+ years of experience in bio study activities including project planning, m...

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USD 40/hr
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Molecular Genetics and Molecular Biology
India
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USD 60/hr

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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M.Sc. Biochemistry and Molecular Biology, Horticulture and Agronomy
United States
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USD 60/hr

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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USD 9/hr

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

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USD 9/hr
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USD 150/hr

Medical writer with experience in pharmacoeconomics, pharmaceutical policy, health policy, and health services research.

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USD 150/hr
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PhD Community Medicine
United States
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USD 250/hr

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

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USD 250/hr
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PhD, Neuropsychopharmacology
United States
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USD 100/hr

I have close to 20 years of experience in human neuropsychopharmacological research at the Department of Psychiatry and Behavioral Sciences. I ...

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USD 100/hr
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United Kingdom
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USD 45/hr

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

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USD 45/hr
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PhD, Neuroscience
United Kingdom
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USD 150/hr

I am the holder of highly prestigious Tier 1 Exceptional Talent Visa and endorsed as such by the Royal Academy of Engineering in the fields of ...

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USD 150/hr
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USD 60/hr

CV • Progressed from fundamental multidisciplinary research (Chemistry, Nanobiotech, Biochemistry) to in vitro Pharmacology (Cell Biology, Targ...

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USD 60/hr
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PhD in Biochemistry
Israel
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USD 60/hr

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

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USD 60/hr
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PhD
Germany
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USD 60/hr

I am Scientific and Medical Writer with 12+ years experience in academic research and writing. I have a Ph.D. in Genetics from one of the top t...

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USD 60/hr
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Master of Business Administration
Malaysia
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USD 40/hr

Regulatory technical writer with experiences in the medical device, pharmaceutical, and cosmetic industries. Demonstrate extensive knowledge in...

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USD 40/hr
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MBA in Healthcare Management
Sri Lanka
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USD 100/hr

I am a medical doctor and a medical writer and editor for the past 8+ years. I have worked with many researchers, surgeons, dermatologists, nep...

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USD 100/hr
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Doctor of Pharmacy
United States
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USD 110/hr

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...

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USD 110/hr
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Ph.D. Pharmaceutical Sciences
United States
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USD 90/hr

Pharmaceutical/Nutraceutical/Food Formulation Scientist with 30+ years of experience developing soft chews, tablet and capsule products, chewab...

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USD 90/hr
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Food Science and Technology
Mexico
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USD 25/hr

Food scientist specialized in consultancy for developing food products and the calculation of food labels with different compliances (FDA, mexi...

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USD 25/hr
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Microbiology (MSc.)
United Kingdom
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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...

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Ph.D (Pharmacology)
India
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USD 12/hr

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

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USD 12/hr
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Medical Writing
United States
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USD 75/hr

I am a PhD-trained medical writer copyeditor with over 4 years of experience. I hold a graduate-level certification in Medical writing and edit...

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USD 75/hr
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Master of Technology - Quality Management
India
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USD 100/hr

A seasoned professional with a decade of experience, I am a Leader and Speaker in the field of Quality Assurance & Regulatory Affairs, ...

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USD 100/hr
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Bachelors of Science in Biochemistry
Switzerland
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USD 200/hr

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...

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USD 200/hr
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Hire top FDA submission experts 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 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.

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.