Hire a Freelance Regulatory Writer: Find an FDA Submission Expert

Viky Gilles Daniel V.

Global Regulatory Affairs Consultant - FDA - Medical Device - Pharma
Create Project
★★★★★
☆☆☆☆☆
USD 150/hr
Global Regulatory Affairs Certification
United States

Guru providing regulatory affairs services to the medical device / medtech, biotech, and pharmaceutical industries. Qualification supported by ...

★★★★★
☆☆☆☆☆
USD 150/hr
Contact3

Joanabel A.

Food Technologist/ Freelance Content Writer
Create Project
★★★★★
☆☆☆☆☆
USD 10/hr
BS in Food Technology
Philippines

I help Food Scientists on their business or projects related to Quality Assurance, Regulatory and Technical Writing.

★★★★★
☆☆☆☆☆
USD 10/hr
Contact3

Paul H.

Freelance Clinical Operations Expert with >15 years of clinical research experience / Phase I-IV international trials...
Create Project
★★★★★
☆☆☆☆☆
USD 165/hr
Bachelor of Science in Nursing (BSN) RN
United States

Experience with all aspects of clinical trial execution, from concept / protocol writing to clinical study report writing. Have worked with a w...

★★★★★
☆☆☆☆☆
USD 165/hr
Contact3

Smita S.

Freelancer_Consultant_Pharmacovigilance audits, Quality consulting
Create Project
★★★★★
☆☆☆☆☆
USD 100/hr
Bachelor of Pharmacy
India

Extensive and Diversified experience in Audits and Compliance, Quality management systems, Process excellence, Training and Coaching. Working ...

★★★★★
☆☆☆☆☆
USD 100/hr
Contact3

Mohan M.

Expert Freelance Consultant Standards, Regulatory Affairs & QMS for Medical Device Design & Manufacture
Create Project
★★★★★
☆☆☆☆☆
USD 125/hr
M.E. (Control Systems)
India

Over 35 years of broad experience as Engineering professional…Medical Device Product Regulatory Requirements, Product Design, Project Managemen...

★★★★★
☆☆☆☆☆
USD 125/hr
Contact3

Stefanie G.

Research Consultant & Grant Writer with 10 years of National Institutes of Health clinical research experience
Create Project
★★★★★
☆☆☆☆☆
USD 40/hr
Master’s of Social Work
United States

I worked for a large healthcare organization conducting NIH medical research for over 10 years. I served as the lead Clinical Research Coordina...

★★★★★
☆☆☆☆☆
USD 40/hr
Contact3

Sinan Ö.

Freelance Data Entry, Market Research Expert with 10+ years of experience
Create Project
★★★★★
☆☆☆☆☆
USD 25/hr
Masters in Chemical Engineering
Turkey

I was born in Çorum in 1989. I graduated from Ege University Chemical Engineering (2012).Gazi University Chemical Engineering Department I...

★★★★★
☆☆☆☆☆
USD 25/hr
Contact3

Chunnan C.

Passionate MedTech innovator with a startup mentality, devoted to application and clinical development of novel techs
Create Project
★★★★★
☆☆☆☆☆
USD 90/hr
Life Science, B.Sc.
Germany

An experienced professional with 20 years of industrial experience in MedTech, biopharmaceutical companies and semi-governmental organizations;...

★★★★★
☆☆☆☆☆
USD 90/hr
Contact3

Matt K.

MPH, experienced in clinical and public health research, program evaluation and management, and qualita...
Create Project
★★★★★
☆☆☆☆☆
USD 40/hr
Master of Public Health- Health Behavior and Health Promotion, Global Health
Ireland

After receiving my MPH in 2016, I have worked in community, clinical, and government where I have developed, implemented, and evaluated variou...

★★★★★
☆☆☆☆☆
USD 40/hr
Contact3

Kathryn V.

Expert librarian with 8 years of experience in systematic reviews
Create Project
★★★★★
☆☆☆☆☆
USD 50/hr
Masters in Library and Information Science
United States

I have almost ten years of experience conducting comprehensive literature searches for evidence syntheses, including systematic reviews. I am a...

★★★★★
☆☆☆☆☆
USD 50/hr
Contact3

Jessica B.

Global Project Leader in CNS | 10+ years of experience in clinical research | ACRP Certified
Create Project
★★★★★
☆☆☆☆☆
USD 50/hr
Master of Science in Clinical Mental Health Counseling
United States

Global Project Leader in Psychiatry & Neurology. Former Research Scientist in Psychiatry. Experienced ACRP Certified Clinical Research Coor...

★★★★★
☆☆☆☆☆
USD 50/hr
Contact3

Biomedical E.

MEDICAL DEVICE REGULATORY CONSULTANT EU-MDR | EU IVDR | SaMD | FDA | MHRA | SFDA | Germany | 7+ years’ Experience
Create Project
★★★★★
☆☆☆☆☆
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...

★★★★★
☆☆☆☆☆
USD 30/hr
Contact3

Roopsandeep B.

Mechanical Engineer, Researcher, Academician, Scientific Technical Writer, Medical Engineer, Ghost Writer, Freelancer
Create Project
★★★★★
☆☆☆☆☆
USD 60/hr
PhD
India

Determined and result-oriented Academician, Researcher, Professional and Entrepreneur, possessing excellent analytical and communication skills...

★★★★★
☆☆☆☆☆
USD 60/hr
Contact3

Smadar K.

Molecular biologist & cancer researcher with 10 years of training and expertise in translational cancer research.
Create Project
★★★★★
☆☆☆☆☆
USD 35/hr
PhD in Biology
Australia

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

★★★★★
☆☆☆☆☆
USD 35/hr
Contact3

Sreejith K.

Active LS Blogger,17 years Biotech experience expert in Validation CSV, Veeva Quality Docs, Information Risk Assessment.
Create Project
★★★★★
☆☆☆☆☆
USD 50/hr
Computer Science Engineering
United States

17 years with multiple consulting gigs across North America and Germany. Completed over 100 Projects.Business mind with Project Management,Risk...

★★★★★
☆☆☆☆☆
USD 50/hr
Contact3

Jigar P.

Medical writer with 7 years of experience in clinical research.
Create Project
★★★★★
☆☆☆☆☆
USD 18/hr
M.Sc. in Microbiology
India

Many thanks for visiting my profile. I have a total of 7 years’ experience in the writing area. Specialized in CSR writing for BA/BE, PK/PD, Tr...

★★★★★
☆☆☆☆☆
USD 18/hr
Contact3

Nazmul H.

Freelance researcher | Expert in cell based therapeutics | 15+ years of experience in academic writing and publishing
Create Project
★★★★★
☆☆☆☆☆
USD 20/hr
PhD
Bangladesh

Experienced cell and molecular biologist specialized in the production of cell-based and cell-free therapeutics. More than ten years of researc...

★★★★★
☆☆☆☆☆
USD 20/hr
Contact3

Laura F.

Commercial Enablement Leader | Strategic Market Analyst | Expert Launching HighSpot
Create Project
★★★★★
☆☆☆☆☆
USD 190/hr
Bachelors
United States

Results-driven commercial enablement leader with 20 years of healtcare-related experience in marketing, sales, training and product management....

★★★★★
☆☆☆☆☆
USD 190/hr
Contact3

Winbell A.

To become a part of the company wherein I can shoulder the job responsibilities in the professional environment and atta
Create Project
★★★★★
☆☆☆☆☆
USD 10/hr
K-12 Curriculum Senior High School
Philippines

I am hardworking, patient and have the willingness and ability to learn new things. I attended Advanced Call Center Agent Training, Advanced En...

★★★★★
☆☆☆☆☆
USD 10/hr
Contact3

Emil K.

Clinical research specialist with 10 years+ experience of designing and implementing complex clinical trial projects
Create Project
★★★★★
☆☆☆☆☆
USD 75/hr
Master of Medical Science
Greece

Expert in clinical trial design, phase II/III infectious diseases research, LMIC settings, risk analysis, and trial project evaluations

★★★★★
☆☆☆☆☆
USD 75/hr
Contact3

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.

pay-per-click
Confidentiality Assured

We take several measures to help you work with full confidence and peace of mind.

Keep your project private

Restrict who can see your project and send you proposals. Invite only specific freelancers to view your project.

NDAs and IP protection

Our T&C include a default confidentiality clause that protects your IP and NDA for added protection before disclosing project details.

Kolabtree ensures safety and security of your payments and personal information and project details. Kolabtree’s T&C includes a default confidentiality and NDA clause.

You will receive detailed proposals directly from Kolabtree. These proposals will include a comprehensive Statement of Work (SOW), project fees, milestones, and deadlines.

You can choose to pay either a fixed or an hourly fee based on your scope of work. Pre-pay for the next milestone. You have to approve the deliverables only if the quality meets your expectations. If you arn’t happy, we’ll refund your money.

Kolabtree will share multiple quotations for your project. You have the freedom to accept the quote that aligns with your project requirement and budget. You can get in touch with us in case you want to discuss the fee.

Our T&C include a default confidentiality clause that protects your IP and NDA for added protection.

Why Kolabtree

Contact experts directly

Speak directly with freelancers and explain your requirements.

100% satisfaction guaranteed

You have to approve the deliverables only if quality meets your expectations. If you arn’t happy, we’ll refund your money.

Project Management

Keep track of files and conversations in the user-friendly Workspace.

Flexible, secure payments

You can choose to pay either a fixed or an hourly fee based on your requirement.

Recent Projects
  • Hiring for fda regulatory affairs consultants
    $550.00
  • Need to outsource a fda regulatory affairs expert
    $450.00
  • Looking for a regulatory writer for mini project
    $450.00
  • Senior regulatory medical writer required for a complex project
    $500.00
  • CMC regulatory writer needed
    $550.00
How it works View full page
1

Post your Project (Free)

Your project details are safe, secure and visible only to logged-in users.

2

Get Quotes & Choose Experts

Discuss your requirements in detail with the experts before accepting the final statement of work from Kolabtree.

3

Collaborate

Pre-pay for your project and work with the expert to get your desired output. Keep track of files and conversations in the user-friendly Workspace.

4

Job Done!

Approve the deliverables once you're satisfied with the job done.

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.