Apac Regulatory Affairs Manager

Johnson & Johnson Innovative Medicine

Koto, Japan
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Apac regulatory strategy
Product registration in ap countries
Health authority interactions
** Johnson & Johnson is seeking an APAC Regulatory Affairs Manager to lead regional regulatory strategies for assigned products in the oncology therapeutic area. The role requires collaboration with local and global teams, ensuring compliance with regional regulatory requirements while providing strategic input for successful product registrations. **

Job Summary

  • The Regional Regulatory Manager Asia Pacific is responsible for defining and implementing the regional strategy for assigned products, providing regulatory strategic input, and ensuring successful regulatory filings.
  • This role involves managing regulatory interactions with local operating companies and regional functions, serving as a point of contact, and ensuring collaborative relationships with key stakeholders.
  • The position requires hands-on experience in pharmaceutical product registration in AP countries, familiarity with AP regulatory systems, and the ability to handle multiple projects while communicating effectively to senior management.

Matching Summary

Match Score: 75

** Johnson & Johnson is seeking an APAC Regulatory Affairs Manager to lead regional regulatory strategies for assigned products in the oncology therapeutic area. The role requires collaboration with local and global teams, ensuring compliance with regional regulatory requirements while providing strategic input for successful product registrations. **

Skills & Requirements

Must-have

  • APAC regulatory strategy
  • product registration in AP countries
  • health authority interactions
  • regulatory submissions
  • lifecycle management

Nice-to-have

  • cultural sensitivity
  • proactive team player
  • achievement-oriented
  • flexibility and adaptability

Key Requirements

  • Minimum 8+ years of overall experience (5+ years relevant pharmaceutical industry and regulatory experience)
  • Bachelor’s degree or equivalent in pharmacy or life-science or health-related discipline
  • Hands-on experience in pharmaceutical product registration in AP countries
  • Familiarity with AP regulatory systems and product registration requirements
  • Previous experience in preparing documents for health authority submissions

Work Rights

Not specified

Tailored Resume

Cover Letter