Senior Regulatory Affairs

About the Role
We are looking for an Senior 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.
Key Responsibilities
1. Lead RA PAT Product Group (HC Portfolio)
• Delegate tasks and manage the RA sub-team.
• Coach and develop team members on regulatory activities related to their assigned products.
• Support the RA Manager on team management tasks including strategic planning and budget control.
2. Product Registration & GMP Assessment (PAT-HC)
• Work with Local Marketing to confirm registration needs and collect required documents.
• Assess documents, prepare and submit registration dossiers.
• Follow up on approvals and submit supplemental dossiers when required.
• Coordinate and submit variation dossiers for change management.
• Collaborate with local R&D to confirm registration requirements and gather documentation.
3. Regulatory & Internal Process Updates
• Stay updated on all regulations related to medical device and drug registration.
• Understand and follow internal processes of local HA (IMDA, DAV); implement updates timely.
• Share regulatory updates with the RA team and relevant departments.
4. Cross-functional Support
• Provide required documents for tender activities.
• Coordinate with Sales & Marketing and SCM for importation of registered products.
• Provide legal/technical documents for customs clearance and other processes.
5. Artwork (AW) Development
• Develop artwork after receiving product registration approval.
• Keep SCM informed of AW development timelines and any changes.
6. QA Coordination
• Support QM and act as the single point of contact with local Health Authorities for all quality management procedures.
Key Working Relationships
Internal
• Sales & Marketing: registration alignment, tender support.
• SCM: ensure compliant importation of registered products.
• QM: support quality-related procedures and tender activities.
External
• Local importer/distributor: quota applications & related activities.
• Health Authorities (IMDA, DAV): submission, follow up, regulatory updates.
• Global/Inter-company RA: request/coordinate documents and global registration fees.