Sr. Manager, ASEAN Lead
On-site · Singapore, Singapore or Petaling Jaya, Selangor, Malaysia
Job Summary
Senior regulatory leadership role overseeing regional Regulatory Affairs for ASEAN at DePuy Synthes (Johnson & Johnson). Lead regional regulatory strategy, product registrations, renewals, variations, and lifecycle activities across ASEAN markets; partner with Commercial Quality, Supply Chain, and R&D to support launches and issue management; ensure compliance with local and international regulatory requirements (ASEAN, MOH/HSA/NMPA/PMDA equivalents); mentor regional RA professionals; drive regulatory intelligence, risk assessment, and governance; represent Asia in global regulatory discussions, audits, and health authority interactions; travel within Asia. English fluency required; RAC preferred; moderate international travel expected.
Required Qualifications
- Bachelor’s degree in Life Sciences, Engineering, Pharmacy, or 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
- 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
- Preferred: orthopedics or complex medical device portfolios; experience interacting with ASEAN health authorities at senior level
- RAC or equivalent regulatory certification preferred, not required
- Fluency in English; additional ASEAN languages a plus
- Moderate international travel within Asia, as needed
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