Hire Freelance Regulatory Writers: Find an FDA Submission Expert

PhD
United States
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USD 75/hr

Experience in craniofacial genetics, medical imaging on postdoctoral level. Experience in market research, intellectual property landscape and ...

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USD 75/hr
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Masters in Pharmacy (Pharmacology and Toxicology)
United States
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USD 50/hr

I am an experienced health professional, having 6+ years of thorough working experience in clinical research and the therapeutic research indus...

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USD 50/hr
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PhD
United States
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USD 200/hr

Co-Founder of RetroBioTech, a consulting firm providing CAP-CLIA assay validation, FDA filing services, Shandi Ingredients developing nutraceut...

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USD 200/hr
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MS - Biomedical Engineering
India
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USD 20/hr

A passionate lifelong student of Biomedical sciences with a Master’s degree from Carnegie Mellon University (CMU), I have always been fascinate...

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USD 20/hr
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Ph.D. student
United States
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USD 160/hr

R&D executive with a Masters in Plastics Engineering and 20 years of experience in the medical device industry; worked in both large-ca...

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USD 160/hr
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PhD
United States
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USD 100/hr

Experienced medical writer with expertise in clinical writing (clinical trial protocols, study reports, IBs, ICFs) and regulatory writing (IND,...

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USD 100/hr
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MS
India
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USD 70/hr

We are a Contract Research Organization (CRO) that focuses on advanced project management, clinical operations, medical writing, statistical an...

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USD 70/hr
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Speed Woman Mentoring
Brazil
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USD 40/hr

Graduated in Biological Sciences (Bachelor's degree) at São Camilo University Center (2008). Science Master’s degree (2012) and Ph.D. ...

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USD 40/hr
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Master of Public Health (M.P.H.), Fundamentals of Clinical Trials
India
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USD 90/hr

A strong background in viorology, medical microbiology and public health qualifies me to work on COVID-19 projects (factsheets, COVID-19 at hom...

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USD 90/hr
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Doctor of Philosophy (Ph.D)
Switzerland
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USD 50/hr

An accomplished biomedical scientist with 7+ years of consulting & medical writing experience. Recognized for excellent scientific writ...

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USD 50/hr
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MSc Medical Statistics
Nepal
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USD 30/hr

I am a pro-active person trained in clinical pharmacology and biostatistics. Currently, I'm leveraging my clinician skills in the improveme...

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USD 30/hr
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PhD in Biology
India
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USD 35/hr

I have many years of experience in biochemistry, molecular biology, and bioinformatics with an emphasis on enzymes and other metabolic proteins...

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USD 35/hr
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United States
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USD 85/hr

Loren DeVito, PhD, is a science and medical writer with expertise across a wide range of therapeutic areas, including oncology, neurology, card...

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USD 85/hr
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BS- Nursing
United States
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USD 150/hr

More than 17 years working as Health Care Consultant for different companies and agencies, as well as a professor from a private and public un...

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USD 150/hr
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MD Pharmacology
India
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USD 30/hr

Medical Doctor & academician turned into pharmaceutical professional. +15 years of experience with leadership positions in drug develop...

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USD 30/hr
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Ph.D. - Biochemistry and Molecular Biology
India
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USD 50/hr

Global professional, doctoral-level research experience in life sciences. Experienced in scientific writing, ICH-GCP E6 framework, clinical res...

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USD 50/hr
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PhD
United States
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USD 50/hr

I am a Ph.D. in Bioengineering with expertise in medical device development and innovation, experimental design, data analysis and interpretati...

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USD 50/hr
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Doctors in Analytical chemistry
India
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USD 30/hr

Having an experience of more than 15 years in the analytical and regulatory domain with sound technical understanding to fulfill different regu...

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USD 30/hr
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Ph.D.
India
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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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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 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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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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PhD
Pakistan
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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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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.