Hire Freelance Regulatory Writers: Find an FDA Submission Expert

PhD
Taiwan
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USD 90/hr

Wing Chuang is specialized in clinical trial protocol development, in compliance with local regulatory requirement, in co-operation with toxico...

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USD 90/hr
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PhD, Biochemistry and Molecular Biology
Italy
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Ala Santos has 15+ years of multidisciplinary experience spanning cancer and cardiomyopathies research. On the top of the technical expertise, ...

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PhD Biological Scinces
Switzerland
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USD 50/hr

Formerly RA Manager at ETH Zurich

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USD 50/hr
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Medical Degree (MD)
India
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Operon Strategist is a medical device consulting companies which provides regulatory guidance to various manufacturers in the healthcare indust...

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PhD
United Kingdom
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USD 60/hr

I have nine years of experience in the field of animal science encompassing academic research, public health and regulatory institutes. I am a ...

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USD 60/hr
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P.h.D. Analytical Chemistry
India
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I lead and support drug development and production for clinical development and commercial products. I have two years working experience in pha...

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PhD (Chemistry)
India
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USD 500/hr

30 plus years of experience in analytical development, Quality, and Regulatory submission in drug substances and drug product

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USD 500/hr
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PhD - Experimental Pharmacology
Australia
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USD 75/hr

• Solid knowledge of Good Clinical Practice guidelines, Medical Code of Conduct and local clinical trial regulatory requirements. • Medical an...

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USD 75/hr
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Biostatistics specialist
Cuba
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USD 50/hr

I have experience in the preparation of analysis plan and statistical processing report. I perform statistical processing in R, SPSS, Python, E...

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USD 50/hr
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Contact
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USD 30/hr

A competent pharma professional with experience in Scientific writing, Regulatory competitive intelligence, DRA, F&D, MSAT and QA. Experie...

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USD 30/hr
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PhD
United States
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USD 21/hr

-Biomedical scientist with over 5 years of research experience and a strong background in a wide range of research areas such as Oncology, Mole...

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USD 21/hr
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BS - Molecular Biology
United States
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USD 250/hr

I have 12 years experience, starting as a Lead Coordinator at a clinical research site. Worked in the CRO space in study start-up, as a CRA, Cl...

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USD 250/hr
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Bachelor's of Science and Associates of Business Administration
United States
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I am an experienced Quality and Regulatory professional with over 25 years in the medical device manufacturing industry. I have worked with Cla...

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Certification
United Kingdom
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USD 40/hr

Hi, Welcome to my profile. Are you looking for a great writer who can commit at least 20 hours or more to work per week? Are looking for can...

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USD 40/hr
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MD
United States
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Mark Luhovy, MD is a medical doctor and biomedical engineer who has dedicated 20 years to the pursuit of understanding the intersection of medi...

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MD
India
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USD 100/hr

Certified Physician (M.D.) with 50+ publications, serving editor/reviewer in 5+ major medical journals. Overall, 10+ years of experience in sci...

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USD 100/hr
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USD 20/hr

Clinical trial expert who brings years of clinical, as well as content development experience in the pharma/device industry, to any projects I ...

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USD 20/hr
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Advanced Clinical Research Graduate Certificate
United States
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USD 45/hr

A Healthcare Professional with 12 years of experience in medical devices and Pharmaceuticals. Astute writer with excellent copy editing skills ...

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USD 45/hr
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MD (Pharmacology)
India
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USD 10/hr

Hi, I have done MBBS and MD in Pharmacology. I have a work experience with Indian giant Pharmaceutical companies. I have developed Medicomarket...

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USD 10/hr
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Contact
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USD 70/hr

I have more than 15-year experience in the food industry with focus on managing and overseeing production processing, quality control and R and...

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USD 70/hr
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Master of Science
India
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USD 50/hr

An experienced Regulatory Affairs professional with significant industry know-how across food supplements/nutraceuticals/foods products. I am a...

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USD 50/hr
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Master of Pharnmacy
India
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USD 20/hr

I am having experience in Medical writing, Regulatory affairs, Pharmacovigliance, i am able to do dossiers work, Licence work.

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USD 20/hr
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Master of Science
Canada
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USD 90/hr

I have 12 years of research experience in fields of oncology, cardiology, orthopedics, biomaterials, tissue engineering, drug delivery, materia...

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USD 90/hr
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Doctor of Pharmacy
India
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USD 50/hr

• Scientific Writer with experience in end-to-end handling of Clinical Evaluation Reports (CERs, both MDD and MDR compliance). • Authored scien...

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USD 50/hr
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Post Graduate Diploma in Management (PGDM)
India
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USD 40/hr

We are a team of experienced regulatory compliance expertise for Medical Devices and In-Vitro diagnostic devices across all risk classes. We ha...

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USD 40/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.