Senior Manager, APAC, Regulatory Affairs, Immunology
On-siteSingapore, Singapore
Job Summary
Define and implement the regional regulatory strategy for the Immunology therapeutic leader in APAC, aligning multi-national approaches with global development teams. Lead long-term regulatory initiatives to support capability development in China and Japan, while providing strategic input into compound development, registration, and lifecycle management. Manage staff under direct responsibility and guide local affiliates on accelerating submissions and approvals. Represent the region in global forums and health authority meetings, preparing presentations and influencing regulatory outcomes. Drive the long-term growth strategy for regulatory affairs in the assigned therapeutic area, ensuring synergy across countries and functions.
Required Qualifications
- Minimum of bachelor's degree or equivalent in pharmacy or life-science or health-related discipline
- Minimum of 10-12 years of overall experience
- 8+ years relevant pharmaceutical industry experience
- at least 5 years of regulatory experience
- Masters/PharmD and 8+ years
- PhD and 6+ years
- Hands' on experience in pharmaceutical product registration in AP countries and regulatory systems and product registration requirements
- Previous experience in preparing documents for health authority submissions (Clinical Trial Application, Chemistry & Manufacturing, and or Registration dossiers)
- Demonstrated leadership and contribution to drug development strategies
- Demonstrated ability to handle multiple projects
- Demonstrated organizational skills
- Ability to communicate to senior level management
- Working knowledge of regulations in the region
- Experience in HAs interactions
- Experience specifically in the therapeutic area
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