Associate Director, Regulatory Affairs

BeOne Medicines

Base: $146,700.00 - $196,700.00 annually; bonus/eq...
8+ years regulatory experience
Ind/cta nda/maa submission management
Fda can ich regulatory knowledge
The role involves developing and implementing regulatory strategies to secure market access for cancer-fighting products

Job Summary

  • The role involves developing and implementing regulatory strategies to secure market access for cancer-fighting products.
  • Candidates will manage the full lifecycle of drug development from investigational phases through post-approval commitments.
  • The company offers a comprehensive benefits package including medical, dental, vision, 401(k), and discretionary equity awards.

Matching Summary

The role involves developing and implementing regulatory strategies to secure market access for cancer-fighting products.

Salary

Base: $146,700.00 - $196,700.00 annually; Bonus/Equity: Eligible for annual bonus plan and discretionary equity awards; Benefits: Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off, Wellness

Skills & Requirements

Must-have

  • 8+ years regulatory experience
  • IND/CTA NDA/MAA submission management
  • FDA CAN ICH regulatory knowledge
  • Health Authority interaction leadership
  • Team management and mentorship

Nice-to-have

  • Advanced degree preferred
  • Project Lead experience in Regulatory Affairs
  • Strong business acumen and negotiation skills
  • Creative problem solving for complex issues
  • Collaborative spirit across functional areas

Key Requirements

  • Bachelor's degree with 8+ years related experience
  • Proven track record managing FDA interactions
  • Experience with INDs, NDAs, BLAs, and MAAs
  • Managerial and leadership capabilities across functions

Work Rights

Not specified

Tailored Resume

Cover Letter