Senior Manager Regulatory Affairs

As Senior Manager, RA, you are the on-the-ground regulatory engine for Malaysia operations. Working closely with the CEO and VP, Strategy and Access, you will help shape the regulatory strategy and own the end-to-end execution of regulatory submissions and approvals for our portfolio with NPRA. This is a high-ownership, execution-focused role.

Responsibilities

Regulatory Submissions & Approvals

• Lead the preparation, compilation, and submission of Marketing Authorization Applications (MAA) to NPRA, ensuring dossiers are complete, accurate, and in CTD format. Manage submission timelines proactively — flagging risks early and coordinating with internal teams and partners to keep approvals on track.
• Serve as day‑to‑day liaison with NPRA throughout the review process — responding to queries, coordinating data requests, and tracking approval progress.
• Manage all post‑approval activities including product renewals, variations, labelling up...