Apac Regulatory Affairs Manager

Johnson & Johnson MedTech

Koto, Japan
**
Regional regulatory strategy implementation
Health authority interactions
Product registration and lifecycle management
** Johnson & Johnson MedTech is seeking an APAC Regulatory Affairs Manager to lead regulatory strategies for oncology products across the Asia Pacific region. The ideal candidate will have extensive experience in regulatory affairs and pharmaceutical product registration, particularly in the oncology therapeutic area. **

Job Summary

  • The Regional Regulatory Manager Asia Pacific is responsible for defining and implementing the regional strategy for assigned products within the oncology therapeutic area.
  • This role involves leading regulatory strategic input, ensuring successful regulatory filings, and managing product variations and health authority inquiries.
  • Key responsibilities include developing regional regulatory strategies, managing health authority interactions, and ensuring timely and compliant regulatory submissions.

Matching Summary

Match Score: 75

** Johnson & Johnson MedTech is seeking an APAC Regulatory Affairs Manager to lead regulatory strategies for oncology products across the Asia Pacific region. The ideal candidate will have extensive experience in regulatory affairs and pharmaceutical product registration, particularly in the oncology therapeutic area. **

Skills & Requirements

Must-have

  • Regional regulatory strategy implementation
  • Health authority interactions
  • Product registration and lifecycle management
  • Regulatory intelligence gathering
  • Oncology therapeutic area expertise

Nice-to-have

  • Cultural sensitivity and matrix environment
  • Proactive team player
  • Flexibility and adaptability

Key Requirements

  • Bachelor's degree or equivalent in pharmacy or life-science
  • 8+ years of overall experience (5+ years relevant pharmaceutical industry and regulatory experience)
  • Hands-on experience in pharmaceutical product registration in AP countries
  • Familiarity with AP regulatory systems and product registration requirements
  • Proficiency in English (written and oral)
  • Mandarin/Asian languages preferred

Work Rights

Not specified

Tailored Resume

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