Associate Director, Regulatory Cmc Small Molecule Lead

Biogen

Multiple Locations
$155,000.00-$214,000.00 base; bonus/equity: cash b...
Global regulatory cmc strategy
Small molecule portfolio
Cross-functional team leadership
You will play a pivotal role in shaping and executing the global Regulatory CMC strategy for Biogen’s small molecule portfolio

Job Summary

  • You will play a pivotal role in shaping and executing the global Regulatory CMC strategy for Biogen’s small molecule portfolio.
  • The Associate Director, RegCMC Small Molecule Lead oversees the management and coordination of regulatory CMC activities across assigned projects and products.
  • Biogen offers a full and highly competitive range of benefits designed to support our employees’ and their families physical, financial, emotional, and social well-being.

Matching Summary

You will play a pivotal role in shaping and executing the global Regulatory CMC strategy for Biogen’s small molecule portfolio.

Salary

$155,000.00-$214,000.00 Base; Bonus/Equity: Cash bonus and equity incentive opportunities; Benefits: Medical, Dental, Vision, Life insurances, Fitness & Wellness programs, Disability insurance, Paid time off, Holidays, Paid Maternity and Parental Leave, 401(k) with match, ESPP, Tuition reimbursement

Skills & Requirements

Must-have

  • Global Regulatory CMC Strategy
  • Small Molecule Portfolio
  • Cross-functional Team Leadership
  • Health Authority Interactions
  • CMC Submission Authoring
  • Global CMC Regulations

Nice-to-have

  • Strategic Thinker
  • Collaborative Spirit
  • Pioneering Spirit
  • Inclusion and Belonging Culture

Key Requirements

  • Bachelor’s degree in Life Sciences, Engineering, Biotechnology, or Pharmaceutical Science
  • Minimum 10+ years of relevant experience
  • At least 7+ years in RegCMC
  • Experience with ICH regions
  • Strong leadership and project management skills

Work Rights

Not specified

Tailored Resume

Cover Letter