Principal Scientist, Regulatory Liaison - Immunology
Listed on 2026-10-09
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Pharmaceutical
Regulatory Compliance Specialist, Medical Science Liaison
Role
Lead global regulatory strategist for Immunology projects, responsible for developing and implementing worldwide regulatory pathways to optimize labeling and accelerate approvals.
Responsibilitiesact as the single point of contact for assigned products across development and lifecycle stages; coordinate submissions, interactions with agencies (FDA, EMA), and regional teams; review regulatory documents including marketing applications, clinical reports, and protocols; and guide cross-functional teams on regulatory strategy.
RequirementsB.S./M.S. with 7+ years or PhD/MD/PharmD with 5+ years in drug development, with strong regulatory experience, especially in immunology; proven expertise in global filings and agency interactions; excellent communication and strategic thinking skills.
High Value:immunology, biologics or small molecules, global regulatory strategy, IND/CTA preparation, experience with FDA and EMA.
Work Setup:remote with 10% travel.
We have an opening for a Principal Scientist, Regulatory Liaison - Immunology in United States within Legal, Other.
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