Regulatory Affairs Manager

<p>Report to:<strong> Head of Regulatory Affairs</strong></p><p>Location:<strong> Ho Chi Minh city</strong></p><p> </p><p><strong>Main duties: </strong></p><ul><li>Lead regulatory strategy for projects aligned with business objectives.</li><li>Own end-to-end portfolio: new MA, variations, extensions, site registration, tenders, promotional activities, biologics (innovator/reference), import licenses.</li><li>Provide expertise across chemical drugs, biologics, and medical devices.</li><li>Drive regulatory intelligence and policy advocacy.</li></ul><p><strong><span style="font-size: 10pt;"><span style="font-family: Verdana, sans-serif;"><span style="color: black;">Your roles:</span></span></span></strong><span style="font-size: 11pt;"><span style="font-family: Calibri, sans-serif;"> </span></span></p><ul><li>Develop and execute regulatory strategies, including risk mitigation and critical review of submissions.</li><li>Manage end-to-end regulatory activities for assigned products/projects.</li><li>Track, expedite, and follow up high-impact submissions to ensure timely approvals.</li><li>Lead lifecycle labeling strategy in alignment with global teams.</li><li>Monitor regulatory environment and stakeholders; assess impact and implement mitigation plans to optimize submissions.</li><li>Lead regulatory communication with internal and external stakeholders (health authorities, partners, affiliates), ensuring alignment and proactive issue resolution.</li><li>Maintain communication with affiliates for regulatory coordination and information exchange.</li><li>Ensure compliance with local regulations and corporate policies.</li><li>Manage regulatory documentation and ensure accurate, timely database entry.</li><li>Handle assigned administrative tasks for the RA team.</li><li>Collaborate cross-functionally on commercial, supply, quality, and tender activities.</li><li>Coordinate with GPS and Medical on PSUR and pharmacovigilance activities.</li></ul><p><span style="font-size: 10pt;"><span style="font-family: Verdana, sans-serif;"><span style="color: black;"><strong>Who you are:</strong></span></span></span></p><ul><li style="text-align: justify;">Bachelor of Pharmacy; Master’s degree preferred.</li><li style="text-align: justify;">At least 8 years in Regulatory Affairs (Pharma), including at least 2 years at RA Manager level; experience with imported products and medical devices preferred.</li><li style="text-align: justify;">Strong experience in innovative drug applications.</li><li style="text-align: justify;">Able to independently manage drug registration dossiers with DAV and clinical trial submissions to ASTT, delivering high performance.</li><li style="text-align: justify;">Proven ability to build trust and maintain effective relationships with Health Authorities and Experts.</li><li style="text-align: justify;">Translate regulatory policies into action plans.</li><li style="text-align: justify;">Proficient in regulatory management systems.</li><li style="text-align: justify;">Detailed-oriented, well-organized & a strong team player.</li><li style="text-align: justify;">Agile and high ownership and accountability.</li><li style="text-align: justify;">Strong problem-solving under ambiguity.</li><li style="text-align: justify;">Influencing without authority.</li><li style="text-align: justify;">Execution discipline and proactive follow-up.</li><li style="text-align: justify;">Effective communication skills.</li><li style="text-align: justify;">Fluency in English.</li><li style="text-align: justify;">Proficient in computer and AI usage.</li></ul>