Our client, a global healthcare solutions provider supporting pharmaceutical products and market access across multiple regions, is seeking a Regulatory Affairs Manager to support its growing operations in Southeast Asia.
Responsibilities:
Regulatory Strategy & Submissions
- Develop and implement regulatory strategies supporting product launches and lifecycle management across SEA.
- Prepare, compile, and submit dossiers for new registrations, renewals, variations, and post-approval changes.
- Ensure submissions follow local requirements (e.g., HSA, NPRA, BPOM, Thai FDA, FDA Philippines, DAV Vietnam).
Regulatory Operations & Compliance
- Oversee the full registration process to ensure timely approvals.
- Monitor regulatory and guideline changes assess impact on portfolio and advise internal teams. Review and approve product labelling, artworks, and promotional materials for regulatory compliance.
- Ensure adherence to regional regulations, GMP/GDP standards, and quality management systems.
Documentation & Lifecycle Management
- Maintain accurate regulatory documentation and archives.
- Support regulatory due diligence for new business opportunities or in-licensing evaluations.
Requirements
- Bachelor's degree in pharmacy or related Life Sciences discipline.
- At least 5 years of regulatory affairs experience in pharmaceuticals, biologics, medical devices, or diagnostics.
- Proven experience managing submissions across multiple SEA markets.
- Strong understanding of ASEAN CTD, eCTD (if applicable), and country-specific requirements.
- Excellent communication, stakeholder management, and project coordination skills.
- Ability to manage multiple priorities and work independently in a fast-paced environment.
