Senior Manager Or Associate Director, Lifecycle Ra

BeOne Medicines Ltd

Japan
On-site
Post-marketing regulatory affairs
Pharmaceutical regulations (pmd act)
Regulatory compliance systems
BeOne Medicines Ltd is seeking a Senior Manager or Associate Director for Lifecycle Regulatory Affairs in Japan, focusing on post-marketing compliance and regulatory strategies. The ideal candidate should have a strong background in pharmacy or life sciences, excellent communication skills, and the ability to manage multiple priorities in a fast-paced environment

Job Summary

  • Provide leadership and strategic direction for Regulatory Affairs and Compliance Communication in Japan, primarily in the post-marketing phase.
  • Establish and maintain regulatory compliance systems, including SOPs, internal audits, and governance support.
  • BeOne is a global oncology company committed to radically improving access to medicines for far more patients who need them.

Matching Summary

Match Score: 85

BeOne Medicines Ltd is seeking a Senior Manager or Associate Director for Lifecycle Regulatory Affairs in Japan, focusing on post-marketing compliance and regulatory strategies. The ideal candidate should have a strong background in pharmacy or life sciences, excellent communication skills, and the ability to manage multiple priorities in a fast-paced environment.

Skills & Requirements

Must-have

  • Post-marketing regulatory affairs
  • Pharmaceutical regulations (PMD Act)
  • Regulatory compliance systems
  • Package insert maintenance
  • Regulatory authority inspections
  • CMC variation submissions

Nice-to-have

  • Scientific and business professionals
  • Collaborative and motivated team
  • Passionate interest in fighting cancer

Key Requirements

  • Bachelor degree and/or Master Degree in Pharmacy or life science
  • Ability to work independently
  • Handle multiple priorities
  • Fast-paced environment
  • Excellent interpersonal skills
  • Strong organizational skills
  • Effective written and verbal communication skills
  • Microsoft Word, Excel, MS Project, MS PowerPoint and Outlook proficiency
  • Up to 10% travel

Work Rights

Not specified

Tailored Resume

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