Regulatory Affairs Specialist/Regulatory Scientist - FSP

💼 Full-time🗓 2026-09-01 → 2026-09-27

Core

Develop and execute global and regional regulatory strategies for pharmaceutical programs across development and post-approval maintenance.

Role type

Regulatory Affairs Scientist

Builds

Regulatory submissions (iPSPs, PIPs, ODDs, INDs, BLAs, MAAs) and Health Authority responses

Domain

Pharmaceuticals / Clinical Development

Deliverable

client delivery

Required skills

Regulatory strategy development, submission compilation, Health Authority interaction, risk assessment, clinical trial plan review, inspection/audit support, process improvement

Preferred skills

Competitor intelligence analysis, therapeutic area landscape knowledge, training delivery

Technologies

None stated

Responsibilities

Develop regulatory strategies, compile submission documents, respond to agency queries, assess regulatory risks, review clinical trial protocols, support inspections and audits, improve submission processes

Seniority

Mid-level, hands-on IC

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About thermofisher

Here at Thermo Fisher Scientific, our industry-leading scale means unparalleled commercial reach, unique customer access and a global footprint. Our broad customer base, from research, clinical to commercial production means you can have a broad and significant impact. All while working in an environment where you will be supported, valued and rewarded for your performance. Join our Sales & Marketing team with an unmatched depth of capabilities and help our customers solve some of the world’s toughest challenges.