International Regulatory Affairs Manager

Regulatory Affairs Manager II, International Regulatory Affairs

The Regulatory Affairs Manager II in International Regulatory Affairs is a regulatory specialist with project management capabilities responsible for leading the end-to-end planning, coordination, and execution of assigned deliverables, including tactical delivery of International Marketing Authorisation Applications (MAAs) and Clinical Line Extensions (CLEs) within an assigned Global Regulatory Execution Team (GRET). The role works closely with cross‑functional teams to develop regulatory submission strategy, manage procedures, and ensure timely delivery of business objectives.

Accountabilities / Responsibilities

• Understands the regulatory framework, including regional trends, for various types of applications and procedures for small and large molecules across all regions.
• Provides regulatory input on procedural and documentation requirements as defined by Health Authorities f...