Senior Director and Regulatory Platform Lead GRA CMC, Device and Drug-Device Combinations Human Factors
Core
Lead the development and implementation of innovative regulatory strategies for pure devices and drug-device combinations, with a specific focus on Human Factors to ensure high-quality regulatory filings.
Role type
Senior Director and Regulatory Platform Lead (Human Factors)
Builds
Global regulatory strategies, briefing books, and compliance frameworks for drug-device combination products.
Domain
Pharmaceutical and Medical Devices (Regulatory Affairs)
Required skills
Human Factors expertise, regulatory strategy for combination products, design control, global health authority negotiation, stakeholder influence, risk identification, team leadership
Preferred skills
Experience with FDA/EMA/Notified Bodies, IND/BLA/MAA submissions, industry forum participation, due diligence
Technologies
None stated
Responsibilities
Maintain expertise in CMC and Human Factors guidelines; influence global health authorities and industry stakeholders; advise senior management on Human Factors strategy; review design control documentation (protocols, reports); lead regulatory strategy and briefing book authoring; identify regulatory risks; support global submissions (Core Dossiers, INDs, BLAs, etc.); develop training and tools for the regulatory team.
Seniority
Senior Director, strategic leadership with hands-on platform ownership