Senior Director Regulatory Affairs, Cmc

BeiGene

Remote, US
$204,500.00 - $274,500.00 annually; bonus/equity: ...
Biologics regulatory cmc leadership
Global cmc regulatory strategies
Health authority interactions
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

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.
  • 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

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.

Salary

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

Skills & Requirements

Must-have

  • Biologics Regulatory CMC leadership
  • Global CMC regulatory strategies
  • Health Authority interactions
  • Product lifecycle management
  • Regulatory CMC submissions

Nice-to-have

  • Collaborative spirit
  • Driving excellence
  • Bold ingenuity
  • Patients first

Key Requirements

  • 12+ years pharmaceutical/biopharmaceutical experience
  • 10+ years direct Regulatory CMC experience
  • BA/BS degree, MS/PhD preferred
  • Experience leading teams of 10+
  • Experience with gene therapy, cell therapy, or combination products highly desirable

Work Rights

Not specified

Tailored Resume

Cover Letter