ANATH L.
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Clinical trial expert who brings years of clinical, as well as content development experience in the pharma/device industry, to any projects I ...
Thariq A.
I am having experience in Medical writing, Regulatory affairs, Pharmacovigliance, i am able to do dossiers work, Licence work.
Dr. Akshay D.
Hi, I have done MBBS and MD in Pharmacology. I have a work experience with Indian giant Pharmaceutical companies. I have developed Medicomarket...
Anitha R.
A Healthcare Professional with 12 years of experience in medical devices and Pharmaceuticals. Astute writer with excellent copy editing skills ...
Maria B.
I have more than 15-year experience in the food industry with focus on managing and overseeing production processing, quality control and R and...
Richa K.
An experienced Regulatory Affairs professional with significant industry know-how across food supplements/nutraceuticals/foods products. I am a...
Niranjan A.
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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I am managing R & D project for in-vitro diagnostics, in-vitro drug screening, medical device, and vaccine development. I look into all as...
Rahul A.
I have 12 years of research experience in fields of oncology, cardiology, orthopedics, biomaterials, tissue engineering, drug delivery, materia...
Dr Febin F.
• Scientific Writer with experience in end-to-end handling of Clinical Evaluation Reports (CERs, both MDD and MDR compliance). • Authored scien...
Kavita S.
We are a team of experienced regulatory compliance expertise for Medical Devices and In-Vitro diagnostic devices across all risk classes. We ha...
Marysa M.
Marysa is a Medical Device Regulatory Consultant with over six years’ experience executing clinical-regulatory documentation and demonstrated k...
Bailey A.
Experienced primarily in the field of oncology (adult and pediatric), in both academia and industry.
Manas K.
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Thamizhselvam E.
1.Deep learning expert 2.Medical device documentation- preparation of design summary as per FDA 3.datascience skills 4. 3+ years of experience...
SUNITI T.
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...
Dr kiran R.
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...
Lini S.
Specialities - Well-versed in EU Registration procedures (DC/MR, CP and nationals). - CMC Dossier Development & writing - Regulatory St...
Herbert G.
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...
Suresh S.
Pharmaceutical Regulatory Affairs professional with more than 10+ years in industry experience in Formulations.
K L.
Am a physician with more than 15 years of experience in the field of Clinical Research having expertise in Clinical trials, Medical review, Med...
Sneha .
I am a Masters graduate in Pharmaceutical science with 6 years of education in drug development, clinical trials and regulatory outlook. I am i...
Hermes A.
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...
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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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.
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Hiring for fda regulatory affairs consultants$550.00
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Need to outsource a fda regulatory affairs expert$450.00
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Looking for a regulatory writer for mini project$450.00
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Senior regulatory medical writer required for a complex project$500.00
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CMC regulatory writer needed$550.00
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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 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.