Sr. Manager, ASEAN Lead
On-site · Singapore, Singapore or Selangor, Malaysia
Job Summary
Senior regulatory leadership role focused on ASEAN across DePuy Synthes products, delivering regulatory strategy and operational execution in a complex, multi-market environment. Partner with Commercial Quality, Supply Chain, and R&D to ensure product registrations, renewals, variations, and lifecycle activities comply with local, regional, and international requirements (ASEAN, MOH/HSA/NMPA/PMDA equivalents). Lead and mentor regional regulatory professionals, drive continuous improvement of regulatory processes and governance, and represent the Asia region in global regulatory forums and health authority interactions. English fluency required; travel within Asia expected. This position is based in Singapore or Selangor, Malaysia, with senior leadership responsibilities and a focus on cross-functional collaboration to support launches and lifecycle management across diverse ASEAN markets.
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
- Preferred: prior experience in orthopedics or complex medical device portfolios
- Experience interacting directly with ASEAN health authorities at a senior level
- Certifications: RAC or equivalent regulatory certification preferred, not required
- Language: Fluency in English required; additional ASEAN languages are a plus
- Travel: Moderate international travel within Asia, as needed
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