Director, Regulatory Affairs CMC, Combination Products and Device

Job Description
The Director, CMC Regulatory Affairs – Combination Products and Device is responsible for setting and leading global CMC regulatory strategy for complex, high-impact device and combination product portfolios, programs, or regulatory domains. This role shapes development and lifecycle strategy, anticipates regulatory risk, and enables successful global registration and lifecycle management.

Key Responsibilities
- Set and lead global CMC regulatory strategy for complex device and combination product portfolios, programs, or critical regulatory workstreams
- Shape global regulatory approaches supporting product development, registration, lifecycle management, patient supply continuity, and long-term business objectives
- Influence development, manufacturing, control strategy, and lifecycle decisions with clear understanding of regulatory risk and opportunity
- Lead resolution of complex regulatory issues where regulations are evolving or precedent may be limited
- Guide regulatory risk mitigation and contingency strategies across major programs and submissions
- Oversee regulatory strategy and execution for major global submissions and critical regulatory milestones (IND/CTA, NDA/BLA/MAA, Notified Body Opinion)
- Represent CMC Regulatory Affairs in health authority interactions
- Drive consistent interpretation/implementation of global regulations, standards, and policy trends
- Bridge global/regional/functional stakeholders to ensure alignment and execution
- Contribute to combination product/device regulatory capability building (process improvements, knowledge sharing, talent development)
- Participate in external industry forums/conferences as appropriate

Qualifications
- Scientific degree with extensive directly relevant experience in CMC, device or combination product development, and global regulatory affairs
- 12+ years with BA/BS; 10+ years with MA/MS/MBA; 8+ years with PharmD/PhD
- Significant experience defining and leading regulatory strategies for complex products/technologies/submissions/domains
- Deep knowledge of global regulatory requirements/standards/evolving expectations for devices and combination products
- Proven ability influencing senior cross-functional stakeholders in complex matrix environments
- Strong experience engaging with health authorities
- Strategic acumen, sound judgment, and ability to lead through ambiguity and change
- Advanced communication, presentation, and leadership skills