About the Role
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 updates, and compliance reporting.
Regulatory Strategy Support
- Provide regulatory input during the BD evaluation process — assessing approvability of new assets, identifying data gaps, and giving realistic timeline estimates to support deal decisions.
- Translate regulatory strategy into actionable submission plans for the Malaysian market, advising internal teams on labeling, promotion materials, and clinical data packages.
- Stay current on NPRA guidelines and ASEAN CTD requirements, flagging relevant changes to senior leadership.
Health Authority & Partner Engagement
- Build and maintain a productive working relationship with NPRA, supporting broader health authority engagement strategy in the region.
- Coordinate with licensed partners and CROs to align on dossier content, timelines, and submission strategy for Malaysia with support to other markets as needed.
- Track regulatory milestones for each product and proactively flag risks that could affect deal obligations or commercialization timelines.
Compliance & Regulatory Infrastructure
- Ensure all regulatory activities comply with Good Regulatory Practice (GRP), Malaysian pharmaceutical laws, and internal standards.
- Maintain accurate regulatory documentation, tracking systems, and submission records — contributing to the scalable regulatory infrastructure being built out across the region.
- Support pharmacovigilance, safety reporting, and SOP development as regulatory function grows.
Qualifications
- Bachelor's degree in Pharmacy, Life Sciences, or a related discipline; advanced qualifications are a plus.
Required Skills
- 8+ years of regulatory affairs experience in the pharmaceutical or biopharmaceutical industry, with strong hands-on experience supporting product registration and regulatory activities in Malaysia.
- Proven experience leading regulatory submissions for biologics to NPRA, including regulatory planning, dossier preparation, agency interactions and approval management.
- Solid working knowledge of CTD/ACTD format, NPRA processes, and ASEAN regulatory requirements for biologics.
- Experience coordinating with international partners, licensors, CROs or local agents on regulatory submissions is a strong advantage.
- Demonstrated ability to work independently in an evolving environment, managing ambiguity, establishing process from scratch and driving outcomes.
- Exposure to regulatory submissions across additional ASEAN markets
