Hire a Freelance Regulatory Writer: Find an FDA Submission Expert

Dr. Gabriel G.

Specialist in Technical Writing, Research Analysis, and Materials Engineering
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USD 20/hr
Ph.D in Polymers Engineering
Brazil

Dynamic and accomplished researcher with over 13 years of experience in materials science, blending academic rigor with real-world impact. My...expertise in advanced material characterization has driven innovation and resulted in numerous high-impact publications...

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USD 20/hr
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Dr. Fazeela F.

Expert Consultant Radiologist & Diagnostic Imaging Online Reporting Specialist | Assistant Professor (Radiology)
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USD 80/hr
FCPS (Diagnostic Radiology)
Pakistan

Dr. Fazeela Farid Assistant Professor (Diagnostic Radiology) Expert Consultant Radiologist | 10+ Years of Experience in MRI, CT, X-ray, Ultraso...

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USD 80/hr
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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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Dr. Hani A.

PhD in Molecular Pathology | Medical Doctor (MBBCH) | Expert in Biochemistry & Clinical Research Trial Management
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USD 80/hr
PhD
United States

I am a medical doctor (MBBCH) with a PhD in Molecular Pathology and a Master's degree in Biochemistry, bringing over a decade of experience...

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USD 80/hr
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Dr. Amy N.

Organized Communicator, Educator, Neuroscience, Project Manager, Mentor, Curriculum Designer, Scientific Writer
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USD 75/hr
Doctorate
United States

I am looking for an opportunity where I can be creative and curious to expand my knowledge and network in education, curriculum design, clinica...

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USD 75/hr
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Dr. Alexander D.

Experienced professional in technological innovation, process optimization, and successful grant acquisition.
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USD 275/hr
PhD
Austria

With over a decade of experience leading technological projects, I assist companies in enhancing their innovation capabilities and achieving op...

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USD 275/hr
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Dr. Damien T.

Freelance scientific expert specialized in preclinical development - technical writer
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USD 200/hr
PhD
France

Scientist executive (PhD) and entrepreneur with extensive experience in biotech R&D. Deep technical and scientific expertise (15+ years) in...

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USD 200/hr
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Dr. Shahbaz B.

Professional Academic & Research Writing Services
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USD 20/hr
Master of Public Health (MPH)
Pakistan

Welcome to my profile! With over 15 years of experience in community medicine, I am a dedicated professional with expertise as a doctor, resea...

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USD 20/hr
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Madhoo P.

Subject Matter Expert in Ophthalmology, Preclinical, Pharmacology, Scientific Writing
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USD 100/hr
PhD
United States

Life science researcher with over 15 years of full time work experience at research institutions, universities, and biopharma industries. Exper...

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USD 100/hr
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Dr Romela S.

Veterinarian | Formulation Scientist | Nutritionist
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USD 25/hr
BVSc Honors
Sri Lanka

A national award winning innovator specialized in pet food and pet supplements I'm a registered veterinary surgeon specialized in veterina...

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USD 25/hr
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Adil M.

Researcher/ Writer/ Fact Checker/Data Curator & Data analyst
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USD 20/hr
BSc (Hons) Molecular Genetics and Molecular Biology
Pakistan

Dear Employers, I am a Professional researcher, writer, fact-checker, and analyst with a Master's Degree in Molecular Biology. My natural...

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USD 20/hr
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ANATH L.

Founder/CEO at DADYMINDS
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USD 25/hr
NATIONAL TVET CERTIFICATE V
United States

5 years in research and writing as an influential author| Expert in business management and mental health services| Plus expertise in Global Br...

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USD 25/hr
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Mark L.

Digital Health Consultant, Medical Doctor, Biomedical Engineer, Certified PMP, Lean Six Sigma Black Belt, 12 yrs med dev
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MD
United States

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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Dr. Ana Luiza C.

Freelance Medical writer, Clinical specialist and Regulatory affairs of Medical Devices, Ph.D. Biological Sciences
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USD 69/hr
MBA Quality Management
Brazil

I have over 8 years of experience in Clinical Research, Regulatory Affairs and Quality Assurance of implantable and electro medical devices in ...

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USD 69/hr
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Dr. Maartje W.

Experienced Medical and Science Writer and Editor - Specialized in Oncology, Immunology, Gynecology, and Healthy aging
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USD 150/hr
PhD
Canada

I am a freelance medical and science writer with over 10 years of biomedical research and medical writing experience in oncology, immunology, a...

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USD 150/hr
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Dr. Ahram Q.

Expert Life Science's Researcher, writer, and Consultant
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USD 50/hr
MPhil in Bioinformatics
Pakistan

My professional background is to technically write the Scientific content, assess the researcher in research work related to Bioinformatics and...

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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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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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Johannes e g Hans V.

Global Expert in Quality engineering management, Auditing, and Regulatory Compliance, SQE. Delivering results for proces
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USD 125/hr
BSc Engineering
Netherlands

Eager to contribute with my passion for quality improvement, attention to detail, and auditing expertise, ensuring success process architecture...

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USD 125/hr
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Biomedical E.

MEDICAL DEVICE REGULATORY CONSULTANT EU-MDR | EU IVDR | SaMD | FDA | MHRA | SFDA | Germany | 7+ years’ Experience
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USD 30/hr
MS Biomedical Engineering
Pakistan

I am Umair Ahmed, a seasoned Biomedical Engineer and Scientist offering over 7 years of comprehensive experience in the freelance medical devic...

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USD 30/hr
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Dr. Shyam Nikethen G.

Medical writer with expertise in producing Regulatory compliant CSR, protocols and SAE reports and Summaries
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USD 10/hr
PharmD (Doctor of Pharmacy)
India

With immense knowledge on Adverse Drug Reaction(ADR) monitoring and reporting, patient care, counselling, prescription monitoring, drug interac...

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USD 10/hr
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Dr. GURDEEP SINGH S.

Development of regulatory compliant process technologies for API's, Speciality Organic, OLEDs and perfumery chemi...
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USD 100/hr
PhD (Chemistry)
India

I have hands on R & D exposure of 42+ years in the development of new synthetic methodologies for carbocyclic...and heterocyclic compounds, natural product as well as Organometallic Chemistry. ( 13 international publications...

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USD 100/hr
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Dr. Sonika V.

Medical Writer and researcher having 10 years of post qualification experience in clinical and epidemiological research.
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USD 70/hr
Diploma in Applied Epidemiology
India

Experienced Medical Writer with a demonstrated history of working in the pharmaceutical industry and research organizations of international re...

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USD 70/hr
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Dr. Hrishikesh G.

Over 30 years of experience commercializing medical devices for large, mid-size and early stage companies.
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USD 125/hr
PhD in Electrical Engineering
United States

Broad hands-on software and hardware development for medical devices such as diagnostic imaging devices (PET, MRI, X-Ray and Ultrasound), blood...

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USD 125/hr
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Dr. Sanet A.

Experienced clinical research and health consultant providing consulting, training and medical writing.
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USD 100/hr
Certificate in Leadership & Performance Management
South Africa

I provide clinical research and health consulting, medical writing and training services to Pharma, Biotechnology Companies, CROs, NGOs, Founda...

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USD 100/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.