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)
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
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
