Manager Combination Products - Regulatory Affairs
Core
Support global combination product development, regulatory submissions, and post-market activities for life-changing medicines.
Role type
Manager, Regulatory Affairs (Combination Products)
Builds
Regulatory filings (INDs, BLAs, MAAs), design control documentation, quality systems, and SOPs for combination products.
Domain
Biotechnology / Pharmaceutical Regulatory Affairs
Required skills
Global CMC Regulatory Affairs, Combination Products, Human Factors, Marketing Authorizations, CTA/INDs, Post-approval submissions, Biologics, FDA engagement, Compliance, Mentoring
Preferred skills
Biologics, Combination Products, FDA engagement
Technologies
None stated
Responsibilities
Support combination product development from early phase through post-market; Review regulatory filings including INDs, BLAs, MAAs, annual reports, and supplements; Develop design control documentation and quality systems; Assess changes and deviations for regulatory impact; Support regulatory authority meetings, responses, and inspections; Create SOPs, Working Instructions, and Reviewer's Guides; Identify process gaps and support regulatory intelligence activities.
Seniority
Manager, hands-on IC with mentorship