Associate Director, RA CMC
Core
Develops and manages CMC regulatory strategies and submissions to enable first-pass approvals for new products and amendments.
Role type
Senior IC regulatory affairs director (CMC)
Builds
Regulatory submissions (INDs/CTAs, marketing applications, supplements) for pharmaceutical products
Domain
Pharmaceuticals / Regulatory Affairs
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
CMC regulatory strategy, regulatory submission management, agency meeting management, change control analysis, policy development, stakeholder negotiation, legislative analysis, team mentorship
Preferred skills
Advanced degree in relevant field, global regulatory strategy experience, Health Authority interaction experience, complex matrix environment experience
Technologies
None stated
Responsibilities
Prepare and manage regulatory submissions including new applications and amendments; Analyze information impacting regulatory decisions; Review and revise submissions to present data to agencies; Manage preparation for and serve as point of contact for agency meetings; Analyze and approve manufacturing change requests; Develop and document internal policies and procedures; Train, develop, and mentor individuals
Seniority
Senior, hands-on IC with leadership responsibilities