Senior Director, Regulatory Affairs CMC Europe & International

Senior Director, Regulatory Affairs-CMC

Reporting to the Executive Director, Regulatory Affairs – CMC, the Senior Director, Regulatory Affairs‑CMC serves as a spokesperson for Regulatory Affairs‑CMC on programs of major import. The role has full responsibility for planning and strategic implementation of global CMC regulatory submission strategies for initial marketing applications and post‑approval life‑cycle management, and collaborates across functions to develop risk‑based approaches and secure timely approvals.

Responsibilities

• Accountability for global CMC regulatory submission strategies for initial marketing applications and post‑approval life‑cycle management.
• Effective cross‑functional collaboration with project teams and external business partners to develop CMC regulatory strategies, identify regulatory risks, and propose options for risk reduction or risk‑based approaches to achieve timely approvals.
• Represent the depar...