Associate Director, Regulatory Cmc (small Molecule)

BeOne Medicines Ltd

Remote
$142,000.00 - $192,000.00 annually; non-commercial...
Small molecule cmc regulatory strategies
Authoring ctd cmc sections
Health authority interactions
BeOne is seeking an experienced and energetic regulatory professional to manage, evaluate, and complete regulatory projects consistent with company goals

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 the aggressive timelines for the assigned projects.
  • The Company has a comprehensive benefits package that includes Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off, and Wellness.

Matching Summary

BeOne is seeking an experienced and energetic regulatory professional to manage, evaluate, and complete regulatory projects consistent with company goals.

Salary

$142,000.00 - $192,000.00 annually; Non-Commercial roles eligible for annual bonus plan, Commercial roles eligible for incentive compensation plan; Equity awards and Employee Stock Purchase Plan participation

Skills & Requirements

Must-have

  • small molecule CMC regulatory strategies
  • authoring CTD CMC sections
  • Health Authority interactions
  • ICH requirements
  • US/EU regulatory requirements
  • GMP regulation knowledge

Nice-to-have

  • collaborative spirit
  • entrepreneurial mindset
  • continuous learning
  • results-oriented
  • analytical thinking
  • familiarity with Veeva

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
  • Experience in authoring complex technical documents, CTD M2 and M3 sections
  • Demonstrated leadership as a people manager

Work Rights

Not specified

Tailored Resume

Cover Letter