Sr. Manager, ASEAN Lead
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Job Function:
QualityJob Sub Function:
Customer/Commercial QualityJob Category:
People LeaderAll Job Posting Locations:
Singapore, SingaporeJob Description:
DePuy Synthes is recruiting for a Sr. Manager, ASEAN Lead located in Singapore, Central Singapore or Selangor, Malaysia.
This senior leadership role provides strategic and operational Regulatory Affairs leadership across ASEAN aligned with Commercial Quality market requirements. The Sr. Manager, ASEAN Lead partners closely with regional and global stakeholders to ensure regulatory compliance, market access, and lifecycle management for DePuy Synthes products across diverse ASEAN markets. This role has a direct impact on business continuity, patient safety, and commercial success, while shaping regulatory strategy in a complex and evolving regulatory environment.
Key Responsibilities
Lead and execute regional Regulatory Affairs strategy for across diverse ASEAN markets, aligned with global Commercial Quality objectives.
Provide regulatory leadership and guidance for product registrations, renewals, variations, and lifecycle activities across ASEAN markets.
Serve as the primary regional RA partner to Commercial, Quality, Supply Chain, and R&D teams to support launches, changes, and issue management.
Ensure compliance with local, regional, and international regulatory requirements (e.g., ASEAN, country‑specific MOH/HSA/NMPA/PMDA equivalents).
Lead, develop, and mentor regional RA professionals, fostering a strong quality and compliance culture.
Oversee regulatory intelligence and risk assessment, proactively identifying regulatory changes and business impacts.
Represent the Asia region in global regulatory forums, audits, and health authority interactions, as required.
Drive continuous improvement of regulatory processes, metrics, and governance across the region.
Qualifications
Education:
Bachelor’s degree in Life Sciences, Engineering, Pharmacy, or a related discipline (required).
Advanced degree (Master’s, PhD, or equivalent) preferred.
Experience and Skills:
Required:
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.
Experience supporting business transformations or operating model changes.
Familiarity with global RA operating models and governance structures.
Strong strategic thinking, risk management, and decision‑making skills.
Other:
Language: Fluency in English required; additional ASEAN languages are a plus.
Travel: Moderate international travel within Asia, as needed.
Certifications: RAC or equivalent regulatory certification preferred, not required.
For more information on how we support the whole health of our employees throughout their wellness, career, and life journey, please visit www.careers.jnj.com.
Johnson & Johnson announced plans to separate our Orthopaedics business to establish a standalone orthopaedics company, operating as DePuy Synthes. The process of the planned separation is anticipated to be completed within 18 to 24 months, subject to legal requirements, including consultation with works councils and other employee representative bodies, as may be required, regulatory approvals and other customary conditions and approvals. Should you accept this position, it is anticipated that, following conclusion of the transaction, you would be an employee of DePuy Synthes and your employment would be governed by DePuy Synthes employment processes, programs, policies, and benefit plans. In that case, details of any planned changes would be provided to you by DePuy Synthes at an appropriate time and subject to any necessary consultation processes.
Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.
Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via https://www.jnj.com/contact-us/careers, internal employees contact AskGS to be directed to your accommodation resource.
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Required Skills:
Preferred Skills:
Compliance Management, Continuous Improvement, Corrective and Preventive Action (CAPA), Developing Others, Fact-Based Decision Making, Give Feedback, Inclusive Leadership, ISO 9001, Leadership, Performance Measurement, Quality Control (QC), Quality Management Systems (QMS), Quality Processes, Quality Standards, Standard Operating Procedure (SOP), Team ManagementYou'll be redirected to
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