Hire a Freelance Regulatory Writer: Find an FDA Submission Expert

Richa K.

Freelance FSSAI Regulatory Expert for Foods, Beverages and Food supplements/Nutraceuticals with 14+ years experience
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USD 50/hr
Master of Science
India

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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Niranjan A.

Clinical Research Consultancy or Clinical Trial Medical Writing Expert
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USD 75/hr
MSc Clinical Trials
India

A versatile person with an impeccable academic record and an insatiable appetite for knowledge, Mr. Andhalkar began his career in Healthcare In...

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USD 75/hr
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Pradip F.

R & D Expert, Scientific Advisor/Strategist/consultant with >20 years of experience in Lifesciences and Healthcar...
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USD 30/hr
M.Sc.
India

I am managing R & D project for in-vitro diagnostics, in-vitro drug screening, medical device, and vaccine development. I look into all as...

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USD 30/hr
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Dr Febin F.

Scientific Writer with 3+ year experience
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USD 50/hr
Doctor of Pharmacy
India

• 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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Rahul A.

Medical Writer, Pharmacist & Biomedical Engineer. 12 years of research experience from around the globe
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USD 90/hr
Master of Science
Canada

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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Kavita S.

Experienced Medical Device Regulatory Affairs professional
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USD 40/hr
Post Graduate Diploma in Management (PGDM)
India

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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Marysa M.

Medical Devices - EU MDR SME - Clinical Eval and PMCF
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USD 200/hr
MSc. Regulatory Affairs
United States

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

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USD 200/hr
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Bailey A.

Freelance Medical Writer with experience in oncology clinical development and precision medicine
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USD 40/hr
United States

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

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USD 40/hr
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SUNITI T.

Scientific writer with creative mindset
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USD 50/hr
MSc.
India

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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USD 50/hr
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Thamizhselvam E.

Experience in data analytics, machine learning and medical devices regulatory.
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USD 20/hr
India

1.Deep learning expert 2.Medical device documentation- preparation of design summary as per FDA 3.datascience skills 4. 3+ years of experience...

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USD 20/hr
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Dr kiran R.

Publication medical writer
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USD 50/hr
Research
India

Dr Akshay Kiran MD (Scientific Manuscript Publication Senior Medical Writer and Statistic...Research Papers, Systematic Review, Literature Review, Meta Analysis, Case Reports ,Review Article for Publication...

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USD 50/hr
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Lini S.

Regulatory Affairs Expert with 20 Years Experience (Regulatory and Scientific Writing Services)
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USD 90/hr
MSc Pharmaceutical Chemistry
India

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

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USD 90/hr
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Suresh S.

Pharmaceutical Regulatory Affairs professional with more than 10+ years in industry experience in Formulations.
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USD 20/hr
Masters in Industrial Pharmacy (M.Pharm)
India

Pharmaceutical Regulatory Affairs professional with more than 10+ years in industry experience in Formulations.

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USD 20/hr
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Herbert G.

I am a business owner and chemist with over 27 years experience in manufacturing, Pharma, R&D, GMP, product developm...
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USD 75/hr
MBA in Entrepreneural Studies
United States

I am a chemist with over 27 years experience. I have also owned several businesses through the years. My work history includes 7 years in R&a...

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USD 75/hr
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Hermes A.

Scientific and technical consultant with 23+ years of experience in Computational Chemistry and Toxicology
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USD 50/hr
Molecular and Cellular Biology, PhD
Canada

I am a chemist with a doctorate in Cellular and Molecular Biology. I have more than 23 years of experience as a researcher and university profe...

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USD 50/hr
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Sneha .

Medical writer skilled in formulation development research, pharmaceutical patent analysis & literature searches.
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USD 15/hr
Master of Science, Pharmaceutical Science
United States

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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USD 15/hr
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K L.

Doctor with 15+ years of experience in clinical research
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USD 100/hr
MD
India

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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USD 100/hr
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Khushbu P.

Regulatory affairs (eCTD submission) with 3+ years of experience. Working as freelancer for PharmaLex (PDE compilation)
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USD 11/hr
Master of pharmacy (Pharmacology)
India

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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USD 11/hr
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Elsa M.

Clinical Project Manager & QPPV @ ICNAS-Produção
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USD 70/hr
The NEW EudraVigilance System and the electronic reporting of ICSRs in the ISO/ICH E2B(R3) format
Portugal

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

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USD 70/hr
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Mike K.

FDA Regulatory Consultant
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USD 150/hr
Bachelor of chemistry and Biochemistry
United States

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 150/hr
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Poornima M.

Scientific and medical writer with 11+ years clinical writing experience
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USD 30/hr
Master in Pharmacy
India

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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USD 30/hr
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Manas K.

Consult/Interim/FT: Plan, Execute: Strat Mktg, NPI/NPD, Intl Biz - Device, Diag, IVD, POC, Tele, Wearable, Cybersecurity
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USD 195/hr
Continuing Education Courses, Certificates, Training: FDA 510K, MDR; NPD, CRM, Finance; CDx, MDx, Strategy
United States

20+ years of planning, developing, executing, managing global strategic upstream marketing initiatives including developing roadmaps for portfo...

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USD 195/hr
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Shiva L.

Regulatory Medical writer with 6.5 years if experience
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USD 60/hr
Molecular Genetics and Molecular Biology
India

Preparation of CER,PER, SSCP, PSURs, PMS Performing Literature search in Literature databases Hands on experience on Literature referencing to...

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USD 60/hr
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Tarana S.

Experienced Bioanalytical Scientist with extensive expertise in Analytical Chemistry, Scientific Writing and Research.
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USD 60/hr
M.Sc. Biochemistry and Molecular Biology, Horticulture and Agronomy
United States

I am a Bioanalytical Scientist with over 15 years of experience in the pharma and biotech industry and extensive expertise in Analytical Chemis...

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USD 60/hr
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Gaurav P.

Biomedical Sciences | Inflammation and oxidative stress cell biology | Electrochemical Biosensor | Data Analytics |
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USD 27/hr

Passionate researcher in disseminating the different domain knowledge for interdisciplinary and real-time application through persistent effort...

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USD 27/hr
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Hire top FDA submission regulatory writers 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 consultants for regulatory writing services.

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How to Hire a Regulatory Writer

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.