Apac Regulatory Affairs Manager

Johnson & Johnson MedTech

Koto, Japan
Not specified
Regional regulatory strategy
Health authority interactions
Pharmaceutical product registration
Johnson & Johnson MedTech is seeking a Regional Regulatory Affairs Manager for the Asia Pacific region to lead regulatory strategy and support for oncology products. The ideal candidate will have substantial experience in pharmaceutical regulatory affairs within the region and will play a key role in ensuring compliance with local regulations while fostering collaboration with various stakeholders

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 leading regulatory filings within the oncology therapeutic area.
  • This role involves ensuring product variations, including labeling changes and renewals, are effected in the region, and providing timely responses to Health Authority inquiries.
  • The position requires managing interactions with local/regional manufacturing sites, tracking changes in country regulatory requirements, and providing regulatory intelligence to regional management and head office.

Matching Summary

Match Score: 85

Johnson & Johnson MedTech is seeking a Regional Regulatory Affairs Manager for the Asia Pacific region to lead regulatory strategy and support for oncology products. The ideal candidate will have substantial experience in pharmaceutical regulatory affairs within the region and will play a key role in ensuring compliance with local regulations while fostering collaboration with various stakeholders.

Skills & Requirements

Must-have

  • Regional Regulatory Strategy
  • Health Authority Interactions
  • Pharmaceutical Product Registration
  • Regulatory Submissions
  • Lifecycle Management

Nice-to-have

  • Cultural Sensitivity
  • Proactive Team Player
  • Achievement-Oriented
  • Adapt to Changing Environment

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
  • Experience in preparing documents for health authority submissions

Work Rights

Not specified

Tailored Resume

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