Senior Director, Clinical Regulatory Affairs

Summary The Senior Director, Clinical Regulatory Affairs will provide strategic leadership across clinical development programs, ensuring regulatory readiness from early-phase through pivotal trials.

This individual will shape and execute clinical-focused regulatory strategies in U.S.

and EU markets, support submission readiness for clinical trial applications (CTAs/INDs), and drive alignment across development functions and geographic regions.

Key Responsibilities Lead development of regulatory strategies for clinical programs (Phase I-III) within cross-functional and global teams, ensuring clinical trial designs and regulatory filings in U.S.

and EU are aligned with business and scientific objectives.

Serve as regulatory lead for clinical submissions including INDs/CTAs, protocol amendments, investigator brochure updates, clinical trial notifications/variations, and interfacing with health authority clinical/regulatory review divis...