Associate Director, Regulatory Cmc (small Molecule)

BeiGene

Base: $142,000.00 - $192,000.00 annually; bonus/eq...
8+ years pharmaceutical regulatory cmc experience
Authoring complex ctd m2 and m3 sections
Leading health authority interactions and responses
The role involves leading the development and implementation of small molecule CMC regulatory strategies to ensure timely global submissions

Job Summary

  • The role involves leading the development and implementation of small molecule CMC regulatory strategies to ensure timely global submissions.
  • Candidates must have a proven record of managing Health Authority interactions including CTAs, NDAs, and MAAs.
  • BeOne offers a comprehensive benefits package including medical, dental, vision, 401(k), and discretionary equity awards.

Matching Summary

The role involves leading the development and implementation of small molecule CMC regulatory strategies to ensure timely global submissions.

Salary

Base: $142,000.00 - $192,000.00 annually; Bonus/Equity: Annual bonus plan eligible; Equity awards available; Benefits: Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, PTO

Skills & Requirements

Must-have

  • 8+ years pharmaceutical regulatory CMC experience
  • Authoring complex CTD M2 and M3 sections
  • Leading Health Authority interactions and responses
  • In-depth knowledge of ICH and US/EU regulations

Nice-to-have

  • Experience with rest of world regulatory regions
  • Familiarity with Veeva software platform
  • Demonstrated leadership as a people manager
  • Background in chemical process or formulation

Key Requirements

  • BA/BS degree required; MS/PhD preferred
  • Minimum 8 years of related industry experience
  • Expertise in GMP regulations and life cycle management

Work Rights

Not specified

Tailored Resume

Cover Letter