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
