Dr. Ahmed E.
An MD with an onging Ph.D. in Healthcare Data Analytics....I have extensive experience within the scope of scientific writing, peer-reviewed publications, advisory...
Dr. GURDEEP SINGH S.
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...
Dr. Hrishikesh G.
Broad hands-on software and hardware development for medical devices such as diagnostic imaging devices (PET, MRI, X-Ray and Ultrasound), blood...
Dr. Kelvin C.
As a highly skilled professional with a PhD in Mathematics, an MSc in Computer Science, and a BSc in Engineering, I have a broad range of exper...
Dr. Jonathan A.
Medical writer with experience in pharmacoeconomics, pharmaceutical policy, health policy, and health services research.
Dr. Nare S.
My science qualification is Ph.D. in pharmaceutical science. My writing qualifications: - Writing in the Sciences Certificate (Stanford Univers...
I was accepted to the MAMF program at Columbia University in 2015 but chose for a variety of reasons to continue the economics doctoral program...
Dr. Jalal A.
I'll write scientific articles or reviews, abstracts, summaries, and assist you in your thesis, format and proofread it. Being a doctoral ...
Dr. Nael A.
Physician with over 12 years of clinical operations experience. Skilled in all aspects of clinical research support including trial management,...
Dr. Archana N.
I am Scientific and Medical Writer with 12+ years experience in academic research and writing. I have a Ph.D. in Genetics from one of the top t...
Dr. Abhay G.
I am a pharmaceutical scientist (Ph.D.) with an extensive publication record, including multiple book chapters, peer-reviewed journal articles,...
I am a medical doctor and a medical writer and editor for the past 8+ years. I have worked with many researchers, surgeons, dermatologists, nep...
An experienced clinical research and medical device Technical file writer who has certified on MEDDEV 2.7/1 Rev#4 documentation, EU MDR 2017/74...
As the medical writer and sole trader of DEKAOKTO solutions, I offer MedComms services, including publication, market research, and conference ...
My professional background is to technically write the Scientific content, assess the researcher in research work related to Bioinformatics and...
Didy Yoga Lucky P.
I have experience in in vitro, in vivo, in silico study, analytical of plant extract, and isolation of metabolite. I also have written study to...
Dr. Hafsa I.
Medical Device Production Manager with 5 years of experience in device development - Technical file - Design File - Procurement - Technology De...
Dr. Pranesh B.
Scientific Literature content review; editing, pre-publication refinement, curation, report authoring. Competitive intelligence; Technology pr...
Hello there! I'm Nauman, 24 years old, a registered dietitian by profession. I have completed my M.Sc. with a specialization in "Pers...
Dr. Arinzechukwu U.
I have over 10+ years experience in medical/content/copywriting and proof-reading/editing as well as over 6+ years experience in cancer researc...
I am a PhD graduate with pharmacology specialization and have experience in handling clinical trial protocols, Clinical study reports, Manuscri...
I have many years of experience in biochemistry, molecular biology, and bioinformatics with an emphasis on enzymes and other metabolic proteins...
Dr. Ana Carolina E.
PhD graduate with 6+ years of biomedical research experience in immunology, vascular biology and auto-immune diseases. Experience in phase III/...
5 years in research and writing as an influential author| Expert in business management and mental health services| Plus expertise in Global Br...
Dr. Zia U.
Synthesis, semi synthesis, isolation and biotranformation of natural products analogous for the treatment of disease. Professional in pharmace...
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 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.