Apac Regulatory Affairs Manager

Johnson & Johnson

Koto, Tokyo, Japan
Not specified (potentially hybrid or remote based on typical industry practices)
Pharmaceutical product registration in ap countries
Familiarity with ap regulatory systems
Oncology therapeutic area experience
Johnson & Johnson is seeking an APAC Regulatory Affairs Manager to lead regulatory strategies for products in the oncology therapeutic area across the Asia-Pacific region. The role involves collaboration with local and global teams to ensure compliance with regional regulatory requirements and support successful product registration. ###

Job Summary

  • The Regional Regulatory Manager Asia Pacific is responsible for defining and implementing the regional strategy for assigned products, including leading and providing regulatory strategic input.
  • This position ensures product variations, labeling changes, and supplements are effected in the region, and provides timely responses to Health Authority inquiries.
  • The role requires understanding regional and local requirements, advising on regulatory guidelines, and participating as a standing member of project-related Global Regulatory Teams.

Matching Summary

Match Score: 85

Johnson & Johnson is seeking an APAC Regulatory Affairs Manager to lead regulatory strategies for products in the oncology therapeutic area across the Asia-Pacific region. The role involves collaboration with local and global teams to ensure compliance with regional regulatory requirements and support successful product registration. ###

Skills & Requirements

Must-have

  • pharmaceutical product registration in AP countries
  • familiarity with AP regulatory systems
  • oncology therapeutic area experience
  • health authority submissions preparation
  • manage regional regulatory interactions
  • develop regional regulatory strategy

Nice-to-have

  • cultural sensitivity and multi-cultural environment
  • proactive team player
  • achievement-oriented
  • high degree of flexibility
  • adapt to changing regulatory environment

Key Requirements

  • Minimum of bachelor’s degree or equivalent
  • Minimum of 8+ years of overall experience
  • 5+ years relevant pharmaceutical industry and regulatory experience
  • Hands-on experience in pharmaceutical product registration
  • Previous experience in preparing documents for health authority submissions
  • Working knowledge of regulations in the region
  • Experience in HAs interactions

Work Rights

Not specified

Tailored Resume

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