Associate Director, Regulatory Cmc (small Molecule)

BeOne Medicines

Base: $142,000.00 - $192,000.00 annually; bonus/eq...
Not specified
8+ years pharmaceutical regulatory cmc experience
Authoring complex ctd m2 and m3 sections
Leading health authority interactions and submissions
BeOne Medicines is seeking an Associate Director of Regulatory CMC for small molecules, focusing on managing regulatory projects related to drug development. The ideal candidate should have over 8 years of experience in regulatory CMC, with a strong background in leading Health Authority interactions and developing regulatory strategies

Job Summary

  • BeOne Medicines is seeking an experienced regulatory professional to lead small molecule CMC strategies for their cancer-fighting mission.
  • The role involves authoring complex CTD sections, managing Health Authority interactions, and ensuring timely global submissions for investigational and market applications.
  • Candidates will benefit from a comprehensive benefits package including medical, dental, vision, 401(k), and opportunities for equity ownership.

Matching Summary

Match Score: 85

BeOne Medicines is seeking an Associate Director of Regulatory CMC for small molecules, focusing on managing regulatory projects related to drug development. The ideal candidate should have over 8 years of experience in regulatory CMC, with a strong background in leading Health Authority interactions and developing regulatory strategies.

Salary

Base: $142,000.00 - $192,000.00 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 pharmaceutical regulatory CMC experience
  • Authoring complex CTD M2 and M3 sections
  • Leading Health Authority interactions and submissions
  • In-depth knowledge of ICH and US/EU regulations
  • Experience with NDA/MAA preparation and responses

Nice-to-have

  • Familiarity with Veeva software systems
  • Knowledge of rest of world regulatory requirements
  • Demonstrated leadership as a people manager
  • Experience in chemical process or formulation development
  • Comfortable working in fast-paced entrepreneurial environment

Key Requirements

  • BA/BS degree required; MS/PhD preferred
  • 8+ years related pharmaceutical industry experience
  • Proven record leading Health Authority interactions
  • Expertise in at least one pharmaceutical development area

Work Rights

Not specified

Tailored Resume

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