Executive - Regulatory Affairs

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.
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.
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.
Artwork (AW) Development
Develop artwork after receiving product registration approval.
Keep SCM informed of AW development timelines and any changes.
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.
Qualifications
Education
Must have:
Pharmacist or related field
Experience
Must have:
Minimum 5 years' experience in RA (pharma) and at least 2 years in an MNC
Strong relationship with DAV
Nice to have:
Experience in medical device RA
Key Skills
Fluency in English
Strong communication & presentation skills
Computer literacy (MS Word, Excel)
Logical thinking & analytical mindset
People management skills