Hire Freelance Regulatory Writers: Find an FDA Submission Expert

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USD 50/hr

Hey there, I am an M.sc, Life Sciences from Banaras Hindu University, India. Currently, I am a professional medical writer with core skills in...

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MSc Pharmaceutical Chemistry
India
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USD 90/hr

Specialities - Well-versed in EU Registration procedures (DC/MR, CP and nationals). - CMC Dossier Development & writing - Regulatory St...

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Masters in Industrial Pharmacy (M.Pharm)
India
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Pharmaceutical Regulatory Affairs professional with more than 10+ years in industry experience in Formulations.

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MD
India
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Am a physician with more than 15 years of experience in the field of Clinical Research having expertise in Clinical trials, Medical review, Med...

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Master in Pharmacy
India
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USD 30/hr

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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Master of Science, Pharmaceutical Science
United States
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USD 15/hr

I am a Masters graduate in Pharmaceutical science with 6 years of education in drug development, clinical trials and regulatory outlook. I am i...

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Master of pharmacy (Pharmacology)
India
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USD 11/hr

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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The NEW EudraVigilance System and the electronic reporting of ICSRs in the ISO/ICH E2B(R3) format
Portugal
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USD 70/hr

Excellent team spirit, own initiative, love teamwork, responsibility and capacity to manage conflicts, ability to adapt to different contexts,...

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Bachelor of chemistry and Biochemistry
United States
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USD 150/hr

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 40/hr

Experienced primarily in the field of oncology (adult and pediatric), in both academia and industry.

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M.Pharm.
India
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USD 90/hr

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

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M.Sc. Microbiology
India
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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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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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PhD in Biology
Australia
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USD 35/hr

10 years of post-PhD experience that includes project management, expertise in patient-tailored assay development, best practice human specimen...

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MSc. Regulatory Affairs
United States
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USD 200/hr

Marysa is a Medical Device Regulatory Consultant with over six years’ experience executing clinical-regulatory documentation and demonstrated k...

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M.Pharm
India
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USD 25/hr

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

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Masters in Pharmacy
India
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My responsibilities include literature search, editing, writing and reviewing process for the development of scientific publications (abstracts...

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

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USD 150/hr

Vision-driven executive with over 21 years of demonstrated leadership in the pharmaceuticals industry. Proven track record of driving bold init...

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Specialization Course in Translation - English
Portugal
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I am an English to Portuguese Medical Translator and Writer working with Life Sciences companies, Contract Research Organizations, Language Ser...

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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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Bachelor of Science in Applied Arts and Sciences Biology
United States
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USD 75/hr

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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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