Over 15 years of experience in Quality and Regulatory Affairs, Risk Assessment, Verification, and Validation, of medical devices like Patient M...
Experience summary: Author and review regulatory periodic safety reports (Periodic Benefit-Risk Evaluation Reports Developmental Safety Updat...
Deep experiece in molecular oncology, NGS, Clinical Research and data management. Autonomy, flexibility, organization and interpersonal skills.
PROFESSIONAL PROFILE: A Regulatory Affairs/ Quality Operations Professional with thirteen years drug development experience (Pharmaceutical), w...
• Preparation of CTD sections of the dossiers required for Regulatory submission in various countries namely EU (National, MRP and DCP), US (AN...
Rob is a Quality System and Regulatory professional with over 20 years of experience in QMS development, deployment, and remediation in the med...
I am currently a cancer researcher at a large pharmaceutical company. My primary scientific background is biology, and I am highly specialized ...
Technical writer with 3 years’ experience executing clinical-regulatory documentation and demonstrated knowledge of EU MDR, clinical evaluation...
A clinical research post-graduate having a vast knowledge over a range of Medical devices consulting services on conformation of 62304:2006 sta...
Guru providing regulatory affairs services to the medical device / medtech, biotech, and pharmaceutical industries. Qualification supported by ...
• Experienced Clinical research professional, with the strong academic foundation of Graduation in Pharmacy and Post-graduation in Biochemical ...
Medical writing specialist: Proficient in developing scientifically accurate and regulatory compliant documents. Niche document expertise inclu...
Experience with all aspects of clinical trial execution, from concept / protocol writing to clinical study report writing. Have worked with a w...
Strongly reliable and focused Regulatory Affairs Specialist with great depth and breadth of experience in medical device regulation and reporti...
I was born in Çorum in 1989. I graduated from Ege University Chemical Engineering (2012).Gazi University Chemical Engineering Department I...
An experienced professional with 20 years of industrial experience in MedTech, biopharmaceutical companies and semi-governmental organizations;...
Global Project Leader in Psychiatry & Neurology. Former Research Scientist in Psychiatry. Experienced ACRP Certified Clinical Research Coor...
I worked for a large healthcare organization conducting NIH medical research for over 10 years. I served as the lead Clinical Research Coordina...
After receiving my MPH in 2016, I have worked in community, clinical, and government where I have developed, implemented, and evaluated variou...
Over 35 years of broad experience as Engineering professional…Medical Device Product Regulatory Requirements, Product Design, Project Managemen...
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.
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.
Kolabtree is the place to go for professional help. Work was done promptly and efficiently. I would definitely seek the service again in my future projects
Maher AnousIndependent Plastic Surgeon, USA
A broad network of skilled people in many fields that is very hard to find elsewhere.
Roger SkagerwallTech entrepreneur, Sweden
The quality and quantity of accessible experts on Kolabtree is priceless.
Webster WatnikProfessor at California State University, USA
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.
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.
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
Post your Project (Free)
Your project details are safe, secure and visible only to logged-in users.
Get Quotes & Choose Experts
Discuss your requirements in detail with the experts before accepting the final statement of work from Kolabtree.
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.
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 40−100 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.