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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.
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
ATS Keywords
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Hard Skills & Tools
Pharmacy DegreeLife-Science DegreeHealth-Related DegreeRegulatory ExperienceProduct Registration RequirementsChemistry & Manufacturing DossiersRegistration DossiersAP Regulatory SystemsLifecycle ManagementCommercialization Strategy
Soft Skills
Verbal CommunicationWritten Communication