Regulatory Affairs Manager •

Regulatory Affairs Manager, Prc Submission Management Lead

Key Responsibilities

Serve as a subject matter expert (SME) in US CPC team, ensuring compliance with regulatory standards and internal processes.

Manage end-to-end MLR review cycles, including submission preparation, routing, and tracking through Veeva Vault.

Collaborate with cross-functional teams to develop and implement regulatory strategies.

Maintain up-to-date knowledge of regulatory requirements and industry trends.