Director, Regulatory Affairs CMC, Combination Products and Device
Core
Setting and leading global CMC regulatory strategy for complex device and combination product portfolios to enable successful global registration and lifecycle management.
Role type
Director, Regulatory Affairs (CMC/Devices)
Builds
Global regulatory strategies for high-impact device and combination product programs
Domain
Biopharmaceuticals, Medical Devices, Combination Products
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Global CMC regulatory strategy, Device/Combination product development, Health authority engagement, Regulatory risk mitigation, Cross-functional stakeholder influence, Lifecycle management
Preferred skills
Strategic acumen, Ambiguity navigation, Process improvement, Industry forum participation
Technologies
Regulatory frameworks (IND/CTA, NDA/BLA/MAA, Notified Body Opinion)
Responsibilities
Lead resolution of complex regulatory issues for combination product programs, Guide development of regulatory risk mitigation strategies, Represent CMC Regulatory Affairs during health authority interactions, Drive consistent interpretation of global regulations for devices
Seniority
Director, Strategic Leadership