Hire Freelance Regulatory Writers: Find an FDA Submission Expert

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USD 30/hr

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

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USD 30/hr
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PhD
United States
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USD 90/hr

Goal-oriented biomedical research with more than 10 years experience and demonstrated achievement in managing clinical/translational research p...

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USD 90/hr
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PhD industrial Engineering
Australia
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USD 155/hr

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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USD 125/hr

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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USD 50/hr

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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Doctor of Philosophy (Ph.D, Pharmaceutical sciences)
India
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USD 30/hr

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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USD 75/hr

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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master of medicine
Kazakhstan
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USD 100/hr

CT: oncology, infections, gastro, gynecology, diabetis

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USD 100/hr
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USD 150/hr

 The RAC qualified Regulatory Professional with more than 17 years of experience. Hold expertise in the global regulatory submissions, approva...

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USD 150/hr
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PhD in Pharmacy
India
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I have twelve years of experience in pharmaceutical analytical research. My core expertise is analytical method development by various techniqu...

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PhD Biomedical Engineering
United States
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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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Statistics for Medical Professionals
Australia
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USD 19/hr

Medical Writer and Grant Writer for 7 years across innovation-intensive research organisations in Australia including the St Vincent’s Centre f...

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USD 19/hr
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PhD Chemistry (Molecular diagnostics for Cancer research; summa cum laude)
Germany
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USD 30/hr

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 20/hr

A competent pharma professional with +10 years of experience in Scientific and medical writings, Regulatory intelligence, DRA, F&D, MSAT, a...

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USD 20/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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Master of Science
United States
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USD 85/hr

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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Synthesis, structural diversification, biological activities and biotransformation of dibenzylacetones: simple chemistry furnishing potent compounds
United States
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USD 95/hr

Synthesis, semi synthesis, isolation and biotranformation of natural products analogous for the treatment of disease. Professional in pharmace...

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USD 95/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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Doctor in Dental Sciences
Pakistan
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USD 335/hr

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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PhD
United States
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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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Ph.D. Pharmacology and Toxicology
United States
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USD 70/hr

* Experience in conceiving, planning, designing, executing, and troubleshooting toxicology studies using various molecular biology, biochemistr...

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USD 70/hr
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Portfolio Management Professional
United States
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USD 150/hr

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

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Doctoral Program
United States
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✰ Open to Work ✰ Available for Short & Long Term Engagements ✰ ✰ Available for due diligence, consulting, advisory, leadership and boa...

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MBA in cosmetic development and marketing
Ireland
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I am a pharmacist and PhD researcher working on glycoengineering of therapeutic antibodies. I have experience with cell culture, upstream and d...

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USD 100/hr

✔ Pharmacovigilance Physician, Medical Regulatory Writer, LQPPV, Project Manager, Clinical Trials Regulatory Expert. ✔13+ years professional me...

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USD 100/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