Apac Regulatory Affairs Manager

Johnson & Johnson

Koto, Japan
On-site
Regional regulatory strategy implementation
Health authority interactions
Product registration lifecycle management
Johnson & Johnson is seeking an APAC Regulatory Affairs Manager responsible for leading and implementing regulatory strategies across the Asia Pacific region, particularly for oncology products. The ideal candidate should possess extensive experience in regulatory affairs within the pharmaceutical industry, with a strong understanding of local regulatory requirements and health authority interactions

Job Summary

  • The position is responsible for defining and implementing the regional strategy for assigned products within the Asia Pacific region.
  • Key responsibilities include leading regulatory strategic input, ensuring timely responses to Health Authority inquiries, and managing product variations.
  • The role requires a deep understanding of regional regulatory requirements and the ability to influence Health Authority actions for successful outcomes.

Matching Summary

Match Score: 75

Johnson & Johnson is seeking an APAC Regulatory Affairs Manager responsible for leading and implementing regulatory strategies across the Asia Pacific region, particularly for oncology products. The ideal candidate should possess extensive experience in regulatory affairs within the pharmaceutical industry, with a strong understanding of local regulatory requirements and health authority interactions.

Skills & Requirements

Must-have

  • Regional regulatory strategy implementation
  • Health Authority interactions
  • Product registration lifecycle management
  • Oncology therapeutic area expertise
  • Regulatory submissions and filings

Nice-to-have

  • Cultural sensitivity and adaptability
  • Proactive team player
  • Achievement-oriented and flexible

Key Requirements

  • Bachelor's degree in pharmacy or life-science
  • 8+ years of pharmaceutical industry experience
  • Hands-on experience in pharmaceutical product registration in AP countries
  • Familiarity with oncology therapeutic area
  • Proficiency in English and preferred Asian languages

Work Rights

Not specified

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