Executive Director, Regulatory Affairs, Cmc

BeiGene

Base: $274,800.00 - $354,800.00 annually; bonus/eq...
Not specified
14+ years pharmaceutical experience
8+ years direct regulatory cmc experience
Lead health authority interactions
BeiGene is seeking an Executive Director for Regulatory Affairs, focusing on U.S. Biologics Regulatory CMC leadership. The ideal candidate will have extensive experience in regulatory affairs specific to biologics, leading a team, and managing high-level interactions with health authorities to ensure compliance and strategic development

Job Summary

  • This role provides strategic and operational leadership for U.S.-based biologics Regulatory CMC activities as a key partner to global stakeholders.
  • The position manages a U.S.-based team of approximately 15 reports and is accountable for high-quality, compliant regulatory submissions supporting clinical development and licensure.
  • BeOne offers a competitive salary range of $274,800 to $354,800 annually along with comprehensive benefits including equity awards and an annual bonus plan.

Matching Summary

Match Score: 85

BeiGene is seeking an Executive Director for Regulatory Affairs, focusing on U.S. Biologics Regulatory CMC leadership. The ideal candidate will have extensive experience in regulatory affairs specific to biologics, leading a team, and managing high-level interactions with health authorities to ensure compliance and strategic development.

Salary

Base: $274,800.00 - $354,800.00 annually; Bonus/Equity: Annual bonus plan eligible; Equity: Discretionary stock awards and Employee Stock Purchase Plan available; Benefits: Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off

Skills & Requirements

Must-have

  • 14+ years pharmaceutical experience
  • 8+ years direct Regulatory CMC experience
  • Lead Health Authority interactions
  • Manage CTD Modules 2 and 3 submissions
  • Oversee IND BLA MAA filings
  • Team leadership of 10+ professionals

Nice-to-have

  • Experience with gene therapy or cell therapy
  • Familiarity with medical device combination products
  • Knowledge of ICH guidelines and GMP regulations
  • Experience with Veeva Vault RIM systems
  • Multilingual capability
  • Background in upstream/downstream processing

Key Requirements

  • BA/BS in scientific disciplines (MS/PhD preferred)
  • Minimum 14 years relevant pharmaceutical experience
  • At least 8 years direct Regulatory CMC experience
  • Proven track record leading teams of 10+ members
  • Hands-on expertise in biologics discipline

Work Rights

Not specified

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