Associate Director, Regulatory Cmc (small Molecule)

BeiGene

Remote
Base: $142,000.00 - $192,000.00 annually; bonus/eq...
Remote
Small molecule cmc regulatory strategies
Ctd cmc sections authoring
Health authority interactions
BeiGene is seeking an Associate Director of Regulatory CMC for small molecules, focusing on managing and executing regulatory projects in a remote setting. The ideal candidate will have extensive experience in regulatory CMC within the pharmaceutical industry, particularly in leading Health Authority interactions and developing regulatory strategies

Job Summary

  • Manage, evaluate, and complete regulatory projects consistent with company goals, focusing on the development of strategies, planning, drafting, and managing CMC-related regulatory submissions and HA interactions.
  • Lead, develop, and implement small molecule CMC regulatory strategies, authoring CTD CMC sections for investigational, market, and post-approval applications to ensure on-time and high-quality global submissions.
  • Provide support to cross-functional teams on CMC regulatory strategies and process optimizations, leading regulatory risk assessment and identifying key CMC regulatory issues and mitigation activities throughout the product life cycle.

Matching Summary

Match Score: 85

BeiGene is seeking an Associate Director of Regulatory CMC for small molecules, focusing on managing and executing regulatory projects in a remote setting. The ideal candidate will have extensive experience in regulatory CMC within the pharmaceutical industry, particularly 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 equity awards; 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
  • CTD CMC sections authoring
  • Health Authority interactions
  • global submissions management
  • cross-functional team collaboration

Nice-to-have

  • process optimizations
  • internal guidance development
  • Veeva familiarity

Key Requirements

  • 8+ years of related pharmaceutical or biopharmaceutical industry regulatory CMC experience
  • BA/BS Degree in scientific disciplines
  • Proven record of leading Health Authority interactions
  • In-depth knowledge of ICH requirements and US/EU regulatory requirements
  • Demonstrated leadership as a people manager

Work Rights

Not specified

Tailored Resume

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