Senior Director Regulatory Affairs, Cmc

beonemedicines.se

$204,500.00 - $274,500.00 annually; bonus/equity: ...
Not specified
Biologics regulatory cmc leadership
Global cmc regulatory strategies
Health authority interactions
BeOne Medicines is seeking a Senior Director of Regulatory Affairs for its U.S. Biologics Regulatory CMC organization, focusing on biologics regulatory strategies and compliance. The ideal candidate should possess extensive regulatory experience, leadership capabilities, and a commitment to fighting cancer

Job Summary

  • This role provides strategic and operational leadership for U.S.-based biologics Regulatory CMC activities and serves as a key partner to the China-based counterpart and global cross-functional stakeholders in the development and execution of global CMC regulatory strategies across the product lifecycle.
  • The position manages a U.S.-based team of approximately 15 reports and reports to the Global Head of Regulatory CMC.
  • The Company has a comprehensive benefits package that includes Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off, and Wellness.

Matching Summary

Match Score: 85

BeOne Medicines is seeking a Senior Director of Regulatory Affairs for its U.S. Biologics Regulatory CMC organization, focusing on biologics regulatory strategies and compliance. The ideal candidate should possess extensive regulatory experience, leadership capabilities, and a commitment to fighting cancer.

Salary

$204,500.00 - $274,500.00 annually; Bonus/Equity: Annual bonus plan and discretionary equity awards; Benefits: Comprehensive benefits package

Skills & Requirements

Must-have

  • Biologics Regulatory CMC leadership
  • Global CMC regulatory strategies
  • Health Authority interactions
  • Monoclonal antibodies, ADCs, cell therapies
  • INDs, BLAs, MAAs submissions
  • Regulatory CMC change-control

Nice-to-have

  • Fighting cancer passion
  • Collaborative and motivated professionals
  • Multilingual capability
  • Gene therapy, cell therapy experience

Key Requirements

  • 12+ years pharmaceutical/biopharmaceutical experience
  • 10+ years direct Regulatory CMC experience
  • BA/BS degree in scientific disciplines
  • MS/PhD preferred
  • Proven experience leading teams of 10+
  • Experience with CTD Modules 2 and 3

Work Rights

Not specified

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