Apac Regulatory Affairs Manager

Johnson & Johnson

Koto, Tokyo, Japan
**
8+ years pharmaceutical regulatory experience
Oncology therapeutic area expertise
Apac regional regulatory submissions
** Johnson & Johnson is seeking an APAC Regulatory Affairs Manager to lead regional regulatory strategies for oncology products across multiple countries in Asia Pacific. The role requires extensive experience in regulatory affairs within the pharmaceutical industry, particularly in product registration and health authority interactions. **

Job Summary

  • The role is responsible for defining and implementing the regional regulatory strategy for assigned oncology products across the Asia Pacific region.
  • Candidates must possess hands-on experience in preparing documents for health authority submissions including Clinical Trial Applications and Registration dossiers.
  • The position requires managing interactions with local operating companies, global R&D partners, and health authorities to ensure successful product registration and lifecycle management.

Matching Summary

Match Score: 75

** Johnson & Johnson is seeking an APAC Regulatory Affairs Manager to lead regional regulatory strategies for oncology products across multiple countries in Asia Pacific. The role requires extensive experience in regulatory affairs within the pharmaceutical industry, particularly in product registration and health authority interactions. **

Skills & Requirements

Must-have

  • 8+ years pharmaceutical regulatory experience
  • Oncology therapeutic area expertise
  • APAC regional regulatory submissions
  • Health authority interaction management
  • Labeling changes and product variations

Nice-to-have

  • Mandarin or Asian language proficiency
  • Matrix environment collaboration skills
  • Strategic thinking in complex environments
  • Cultural sensitivity in multi-national teams
  • Experience with clinical trial placement

Key Requirements

  • Bachelor's degree in pharmacy or life science
  • Minimum 8 years relevant industry experience
  • Familiarity with APAC regulatory systems
  • Proficiency in English communication

Work Rights

Not specified

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