About the Role We are looking for an Executive – Regulatory Affairs (RA) to lead the RA sub-team for the HC portfolio (PAT products) and drive all regulatory activities for product registration, GMP assessment, and compliance with local health authority requirements. This role plays a key part in ensuring successful product registration, regulatory updates, cross-functional coordination, and quality support. <div align="center"><hr align="center" size="2" width="100%"></div> Key Responsibilities 1. Lead RA PAT Product Group (HC Portfolio) <ul type="disc"> <li>Delegate tasks and manage the RA sub-team.</li> <li>Coach and develop team members on regulatory activities related to their assigned products.</li> <li>Support the RA Manager on team management tasks including strategic planning and budget control.</li> </ul> 2. Product Registration & GMP Assessment (PAT–HC) <ul type="disc"> <li>Work with Local Marketing to confirm registration needs and collect required documents.</li> <li>Assess documents, prepare and submit registration dossiers.</li> <li>Follow up on approvals and submit supplemental dossiers when required.</li> <li>Coordinate and submit variation dossiers for change management.</li> <li>Collaborate with local R&D to confirm registration requirements and gather documentation.</li> </ul> 3. Regulatory & Internal Process Updates <ul type="disc"> <li>Stay updated on all regulations related to medical device and drug registration.</li> <li>Understand and follow internal processes of local HA (IMDA, DAV); implement updates timely.</li> <li>Share regulatory updates with the RA team and relevant departments.</li> </ul> 4. Cross-functional Support <ul type="disc"> <li>Provide required documents for tender activities.</li> <li>Coordinate with Sales & Marketing and SCM for importation of registered products.</li> <li>Provide legal/technical documents for customs clearance and other processes.</li> </ul> 5. Artwork (AW) Development <ul type="disc"> <li>Develop artwork after receiving product registration approval.</li> <li>Keep SCM informed of AW development timelines and any changes.</li> </ul> 6. QA Coordination <ul type="disc"> <li>Support QM and act as the single point of contact with local Health Authorities for all quality management procedures.</li> </ul> <div align="center"><hr align="center" size="2" width="100%"></div> Key Working Relationships Internal <ul type="disc"> <li>Sales & Marketing: registration alignment, tender support.</li> <li>SCM: ensure compliant importation of registered products.</li> <li>QM: support quality-related procedures and tender activities.</li> </ul> External <ul type="disc"> <li>Local importer/distributor: quota applications & related activities.</li> <li>Health Authorities (IMDA, DAV): submission, follow‑up, regulatory updates.</li> <li>Global/Inter-company RA: request/coordinate documents and global registration fees.</li> </ul> <div align="center"><hr align="center" size="2" width="100%"></div> Qualifications Education Must have: <ul type="disc"> <li>Pharmacist or related field</li> </ul> Experience Must have: <ul type="disc"> <li>Minimum 5 years’ experience in RA (pharma) and at least 2 years in an MNC</li> <li>Strong relationship with DAV</li> </ul> Nice to have: <ul type="disc"> <li>Experience in medical device RA</li> </ul> Key Skills <ul type="disc"> <li>Fluency in English</li> <li>Strong communication & presentation skills</li> <li>Computer literacy (MS Word, Excel)</li> <li>Logical thinking & analytical mindset</li> <li>People management skills</li> </ul>

Executive - Regulatory Affairs (Hanoi, VN) @ B. Braun Melsungen AG

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