Regulatory Scientific and Health Solutions
Regulatory Scientist / Regulatory Affairs Consultant – FDA Experience
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Role Type: Contract/ Project Based
Location: Remote
Contract: Rolling contract with potential extensions
Hours: Part-time
Rate: Competitive hourly rate, outside IR35, based on experience
Overview
The successful candidate will be responsible for developing and implementing regulatory strategies and collating scientific, clinical, and real-world evidence to support submissions to health authorities and other regulatory bodies. FDA and IRT experience is essential.
Key responsibilities
- Develop and contribute to regulatory strategy for the IRT study and associated clinical development activities, including plans for health authority interactions and submissions.
- Identify FDA and global regulatory submission requirements for each client programme and translate them into clear regulatory and writing plans.
- Gather, collate, and critically evaluate scientific, clinical, and real-world data to support regulatory submissions.
- Prepare, author, and/or review regulatory documents such as clinical trial applications, briefing packages, responses to health authority questions, investigator brochures, nonclinical overviews, and periodic safety/annual reports, ensuring consistency with source study data and reports.
- Coordinate and manage regulatory timelines, deliverables, and documentation workflows, including version control and maintenance of clear, accurate regulatory records.
- Monitor changes in relevant regulations, guidance, and payer/HTA expectations for IRT and related endpoints, and advise study teams on impact to protocol design, endpoints, and submission strategy.
- Contribute to regulatory strategy, including submission plans, health authority interaction materials, and benefit–risk positioning for client assets.
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Requirements
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- Proven experience in regulatory writing within the pharmaceutical, biotechnology, medical device or clinical research sector.
- Demonstrable experience preparing documentation for US FDA submissions and interactions.
- Strong understanding of regulatory requirements and submission processes.
- Excellent scientific writing, editing, and document-review skills.
- Ability to interpret complex technical information and present it clearly and accurately.
- Excellent attention to detail and the ability to work independently to meet project deadlines.
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