Executive Director, Regulatory Affairs, Cmc

beonemedicines.sg

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
BeOne Medicines is seeking an Executive Director for Regulatory Affairs focused on U.S. Biologics Regulatory CMC activities, requiring significant experience in regulatory submissions and team leadership. The ideal candidate will lead a U.S.-based team, ensuring compliance and high-quality regulatory filings while collaborating with global stakeholders in the biologics sector

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.
  • The position manages a U.S.-based team of approximately 15 reports and is accountable for high-quality, compliance, and timely filings supporting clinical development and licensure.
  • BeOne offers a comprehensive benefits package including Medical, Dental, Vision, 401(k), Life Insurance, Paid Time Off, and opportunities for discretionary equity awards.

Matching Summary

Match Score: 85

BeOne Medicines is seeking an Executive Director for Regulatory Affairs focused on U.S. Biologics Regulatory CMC activities, requiring significant experience in regulatory submissions and team leadership. The ideal candidate will lead a U.S.-based team, ensuring compliance and high-quality regulatory filings while collaborating with global stakeholders in the biologics sector.

Salary

Base: $274,800.00 - $354,800.00 annually; Bonus/Equity: Eligible for annual bonus plan and discretionary equity awards; Benefits: Comprehensive package including Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, PTO

Skills & Requirements

Must-have

  • 14+ years pharmaceutical experience
  • 8+ years direct Regulatory CMC experience
  • Lead Health Authority interactions
  • Manage team of 10+ professionals
  • Expertise in CTD Modules 2 and 3
  • Monoclonal antibodies and ADC knowledge

Nice-to-have

  • Experience with gene therapy or cell therapy
  • Medical device–combination product expertise
  • Veeva Vault regulatory system experience
  • Multilingual capability
  • Strong collaborative spirit
  • Global matrixed environment experience

Key Requirements

  • BA/BS Degree in scientific disciplines (MS/PhD preferred)
  • 10+ years innovative drug development/manufacturing experience
  • At least 8 years direct Regulatory CMC experience
  • Proven track record leading teams of 10+ members
  • Hands-on expertise in upstream/downstream processing or formulation

Work Rights

Not specified

Tailored Resume

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