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 ich can regulatory knowledge
The role involves developing and implementing regulatory strategies to secure market access for cancer treatment products

Job Summary

  • The role involves developing and implementing regulatory strategies to secure market access for cancer treatment products.
  • Candidates must manage the full lifecycle of compounds from development through post-approval while ensuring compliance with US, Canadian, and ICH regulations.
  • BeOne Medicines 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 treatment 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

Skills & Requirements

Must-have

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

Nice-to-have

  • Project Lead experience in Regulatory Affairs
  • Advanced degree preferred
  • Strong conflict resolution skills
  • Entrepreneurial mindset
  • Cross-functional collaboration ability

Key Requirements

  • Bachelor's degree required
  • 8+ years related regulatory experience
  • Experience leading FDA interactions
  • Proven track record in IND/NDA submissions

Work Rights

Not specified

Tailored Resume

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