Associate Director, Regulatory Cmc (small Molecule)

BeOne Medicines Ltd

Remote
Base: $142,000.00 - $192,000.00 annually; bonus/eq...
Fully remote
Small molecule cmc regulatory strategies
Authoring ctd cmc sections
Health authority interactions
BeOne Medicines Ltd is seeking an experienced Associate Director of Regulatory CMC for small molecules, responsible for developing and managing CMC regulatory strategies and submissions. The position is fully remote and requires a candidate with extensive pharmaceutical regulatory experience and strong leadership skills

Job Summary

  • BeOne is seeking an experienced and energetic regulatory professional to manage, evaluate, and complete regulatory projects consistent with company goals.
  • This individual will be responsible for development of strategies, planning, drafting, and managing CMC-related regulatory submissions and HA interactions to meet aggressive timelines.
  • The position may or may not manage direct report(s) and requires excellent oral and written communication skills.

Matching Summary

Match Score: 85

BeOne Medicines Ltd is seeking an experienced Associate Director of Regulatory CMC for small molecules, responsible for developing and managing CMC regulatory strategies and submissions. The position is fully remote and requires a candidate with extensive pharmaceutical regulatory experience and strong leadership skills.

Salary

Base: $142,000.00 - $192,000.00 annually; Bonus/Equity: Eligible for annual bonus plan, discretionary equity awards, and Employee Stock Purchase Plan; Benefits: Comprehensive benefits package including Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off, and Wellness

Skills & Requirements

Must-have

  • Small molecule CMC regulatory strategies
  • Authoring CTD CMC sections
  • Health Authority interactions
  • Global submissions
  • Cross-functional team communication

Nice-to-have

  • Veeva familiarity
  • ROW regulatory requirements
  • GMP regulation knowledge

Key Requirements

  • 8+ years of related pharmaceutical or biopharmaceutical industry regulatory CMC experience
  • BA/BS Degree in scientific disciplines, MS/PhD preferred
  • Proven record of leading Health Authority interactions, CTA, NDA/MAA, post-approval preparation, submission, and response to HA queries
  • In-depth knowledge of ICH requirements and US/EU regulatory requirements
  • Demonstrated leadership as a people manager
  • Experience in authoring complex technical documents, CTD M2 and M3 sections, and life cycle management
  • Educational background in scientific disciplines and expertise in at least one area in pharmaceutical development

Work Rights

Not specified

Tailored Resume

Cover Letter