Hire Freelance Regulatory Writers: Find an FDA Submission Expert

M.Sc Clinical Research
India
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USD 10/hr

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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Double Masters
Pakistan
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USD 150/hr

PROFESSIONAL PROFILE: A Regulatory Affairs/ Quality Operations Professional with thirteen years drug development experience (Pharmaceutical), w...

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USD 150/hr
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Masters of Science
United States
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USD 60/hr

M.S. Health Science (Health Administration- Community Health Education and Promotion); 20+ years of human subject (clinical...trials) and community-based participatory research (behavioral; violence prevention, senior health; public...

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USD 60/hr
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BS in Food Technology
Philippines
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USD 10/hr

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

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Master of Public Health
France
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USD 100/hr

I have 15 years of experience in the field of Public Health and Clinical Research in several positions: coordination, monitoring, project man...

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USD 100/hr
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Bachelor of Science in Nursing (BSN) RN
United States
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USD 165/hr

Experience with all aspects of clinical trial execution, from concept / protocol writing to clinical study report writing. Have worked with a w...

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USD 165/hr
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Master in pharmacology
India
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USD 25/hr

Strongly reliable and focused Regulatory Affairs Specialist with great depth and breadth of experience in medical device regulation and reporti...

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USD 25/hr
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Masters in Chemical Engineering
Turkey
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USD 25/hr

I was born in Çorum in 1989. I graduated from Ege University Chemical Engineering (2012).Gazi University Chemical Engineering Department I...

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USD 25/hr
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Master of Public Health
United States
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USD 50/hr

Technical writer with 3 years’ experience executing clinical-regulatory documentation and demonstrated knowledge of EU MDR, clinical evaluation...

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USD 50/hr
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M.E. (Control Systems)
India
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USD 125/hr

Over 35 years of broad experience as Engineering professional…Medical Device Product Regulatory Requirements, Product Design, Project Managemen...

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USD 125/hr
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Master of Public Health- Health Behavior and Health Promotion, Global Health
Ireland
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USD 40/hr

After receiving my MPH in 2016, I have worked in community, clinical, and government where I have developed, implemented, and evaluated variou...

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USD 40/hr
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Masters of Science in Cellular and Molecular Oncology
United States
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USD 62/hr

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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Master’s of Social Work
United States
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USD 40/hr

I worked for a large healthcare organization conducting NIH medical research for over 10 years. I served as the lead Clinical Research Coordina...

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USD 40/hr
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Bachelor of Pharmacy
India
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USD 100/hr

Extensive and Diversified experience in Audits and Compliance, Quality management systems, Process excellence, Training and Coaching. Working ...

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USD 100/hr
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B.Sc. Pharmaceutical and Cosmetic Science
United Kingdom
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USD 75/hr

I have over 10+ years of experience in the development of new products across various dosage forms including oral liquids, semisolids, solids a...

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USD 75/hr
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M.Sc. in Microbiology
India
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USD 18/hr

Many thanks for visiting my profile. I have a total of 7 years’ experience in the writing area. Specialized in CSR writing for BA/BE, PK/PD, Tr...

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USD 18/hr
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Computer Science Engineering
United States
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USD 50/hr

17 years with multiple consulting gigs across North America and Germany. Completed over 100 Projects.Business mind with Project Management,Risk...

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USD 50/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.

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. 

 

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