Regulatory Affairs Manager

Report to: Head of RA
Location: Ho Chi Minh city
Your Roles:
• Lead regulatory strategy for projects aligned with business objectives.
• Own end-to-end portfolio: new MA, variations, extensions, site registration, tenders, promotional activities, biologics (innovator/reference), import licenses.
• Provide expertise across chemical drugs, biologics, and medical devices.
• Drive regulatory intelligence and policy advocacy.
Your roles:
• Develop and execute regulatory strategies, including risk mitigation and critical review of submissions.
• Manage end-to-end regulatory activities for assigned products/projects.
• Track, expedite, and follow up high-impact submissions to ensure timely approvals.
• Lead lifecycle labeling strategy in alignment with global teams.
• Monitor regulatory environment and stakeholders; assess impact and implement mitigation plans to optimize submissions.
• Lead regulatory communication with internal and external stakeholders (health authorities, partners, affiliates), ensuring alignment and proactive issue resolution.
• Maintain communication with affiliates for regulatory coordination and information exchange.
• Ensure compliance with local regulations and corporate policies.
• Manage regulatory documentation and ensure accurate, timely database entry.
• Handle assigned administrative tasks for the RA team.
• Collaborate cross-functionally on commercial, supply, quality, and tender activities.
• Coordinate with GPS and Medical on PSUR and pharmacovigilance activities.