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Manager, APAC, Regulatory Affairs, Immunology
Johnson & JohnsonManager for Regulatory Affairs at Johnson & Johnson, optimizing pharmaceutical registrations and supporting product lifecycle in APAC region. Collaborating with local and global teams to ensure compliance and efficiency.
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in regulatory affairs within the pharmaceutical sector, focusing on product registration, health authority submissions, and regional regulatory strategy implementation. Proficient in communication, particularly in English and preferred Asian languages, to effectively engage with cross-functional teams and regulatory bodies.
Highest-signal resume keywords
Regulatory Affairs ManagementPharmaceutical Product RegistrationHealth Authority SubmissionsRegional Regulatory StrategyCommunication Skills
ATS Keywords
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Hard Skills
Pharmacy DegreeLife-Science DegreeHealth-Related DegreeRegulatory ExperienceProduct Registration RequirementsChemistry & Manufacturing DossiersRegistration DossiersAP Regulatory SystemsLifecycle ManagementCommercialization Strategy
Soft Skills
Verbal CommunicationWritten Communication
Industry Keywords
Pharmaceutical SectorHealth AuthorityAP CountriesRegional AffiliatesCross-Functional Teams
About the role
Key responsibilities & impact- The Manager, Regulatory Affairs is responsible for working with local regulatory affairs departments, AP regional cross-functional teams, Global Regulatory Teams and other global functions to define and implement the regional strategy for assigned products.
- This position provides regional affiliates with timely responses to Health Authority enquiries and gives general regulatory support to all affiliates in the region for the pharmaceutical sector business.
- Drives the development and implementation of the regional regulatory strategy that optimize development, registration, and lifecycle management of new and marketed products.
- Expedites commercialization of new indications and line extension by providing regional regulatory inputs.
Requirements
What you’ll need- Minimum of bachelor’s degree or equivalent in pharmacy or life-science or health-related discipline
- 5-10 years of overall experience in relevant pharmaceutical industry and preferably with regulatory experience.
- Regional experience preferred.
- Hands on experience in pharmaceutical product registration in AP countries and familiarity with AP regulatory systems and product registration requirements preferred.
- Previous experience in preparing documents for health authority submissions (Chemistry & Manufacturing, and/or Registration dossiers) also preferred.
- Excellent verbal and written communication skills – proficiency in written and oral English and [Mandarin/Asian (Asia) languages is preferred.]
Benefits
Comp & perks- Health insurance
- Paid time off
- Professional development
- Flexible work arrangements