Sr. Manager, ASEAN Lead
On-site · Singapore, Singapore or Petaling Jaya, Selangor, Malaysia
Job Summary
Senior leadership role leading regional Regulatory Affairs strategy for ASEAN across DePuy Synthes, providing regulatory leadership for product registrations, renewals, variations, and lifecycle activities. Partners with Commercial Quality, Quality, Supply Chain, and R&D to support launches and issue management; ensures compliance with ASEAN and international requirements; leads and mentors regional RA professionals; drives regulatory intelligence, risk assessment, and governance; represents Asia in global forums and audits; travel within Asia as needed. Fluency in English required; additional ASEAN languages a plus. Requires travel and RAC or equivalent preferred. The role is based in Singapore or Selangor with regional scope across ASEAN; structure includes leadership of regional RA teams and collaboration with multiple functions to enable clinical and commercial success.
Required Qualifications
- Bachelor’s degree in Life Sciences, Engineering, Pharmacy, or a related discipline (required).
- Advanced degree (Master’s, PhD, or equivalent) preferred.
- 10-12 years of progressive experience in Regulatory Affairs and/or Quality Affairs within medical devices, orthopedics, or a regulated healthcare industry.
- Demonstrated experience leading regional or multi-country regulatory activities in Asia.
- Strong knowledge of ASEAN regulatory frameworks and global regulatory standards.
- Proven ability to lead and develop teams and influence without authority in a matrixed organization.
- Experience partnering with commercial and quality organizations to support product launches and lifecycle management.
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