Sr Manager, Regulatory Affairs CMC, Combination Products and Device
Core
Lead CMC regulatory activities for development, registration, and lifecycle management of combination products and devices.
Role type
Senior Manager, CMC Regulatory Affairs (Combination Products & Devices)
Builds
Global regulatory submissions (IND/CTA, NDA/BLA/MAA) and lifecycle management for combination products and devices.
Domain
Biopharmaceuticals, Devices, Combination Products
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
CMC regulatory strategy, global regulatory interpretation, submission management, risk escalation, health authority interaction, regulatory impact assessment, process improvement
Preferred skills
Cross-functional influence, project management, technical translation
Technologies
Regulatory frameworks (FDA, EMA, etc.), Notified Body processes
Responsibilities
Develop global CMC regulatory strategies, lead regulatory workstreams for assigned programs, interpret global regulations for device/combination products, provide input on design controls and lifecycle changes, prepare CMC content for global submissions, partner on submission readiness and risk resolution, support health authority interactions, conduct regulatory impact assessments, maintain knowledge of regulatory trends, contribute to policy/trade working groups, drive process improvement
Seniority
Senior Manager, hands-on leadership