Associate Director, Regulatory Affairs, Cmc

BeiGene

Remote
$142,000.00 - $192,000.00 annually; bonus/equity: ...
Global regulatory cmc strategies
Large molecule development
Module 3 authorship
The AD, Regulatory Affairs, CMC is responsible for developing and implementing global regulatory CMC strategies to secure and maintain market access for assigned product(s) in line with business objectives

Job Summary

  • The AD, Regulatory Affairs, CMC is responsible for developing and implementing global regulatory CMC strategies to secure and maintain market access for assigned product(s) in line with business objectives.
  • This position will manage regulatory CMC aspects of compounds (large molecules) through all phases of development, post-approval, and life cycle of the product.
  • 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

The AD, Regulatory Affairs, CMC is responsible for developing and implementing global regulatory CMC strategies to secure and maintain market access for assigned product(s) in line with business objectives.

Salary

$142,000.00 - $192,000.00 annually; Bonus/Equity: Annual bonus plan or incentive compensation plan, discretionary equity awards, Employee Stock Purchase Plan; Benefits: Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off, Wellness

Skills & Requirements

Must-have

  • global regulatory CMC strategies
  • large molecule development
  • Module 3 authorship
  • Health Authority interactions
  • GMP quality regulations

Nice-to-have

  • collaborative spirit
  • bold ingenuity
  • driving excellence
  • entrepreneurial mindset
  • continuous learning

Key Requirements

  • 8+ years global CMC regulatory affairs
  • Biologics expertise
  • BS/BA Biochemistry, Biology, or Pharmaceutical Science
  • Veeva Data Management System experience

Work Rights

Not specified

Tailored Resume

Cover Letter