Associate Director, Regulatory Cmc Small Molecule Lead

Biogen

Multiple Locations
Base: $155,000.00-$214,000.00; bonus/equity: cash ...
Regulatory cmc expertise
Global regulatory submissions
Cross-functional team leadership
As Associate Director, Regulatory CMC Small Molecule Lead, you will shape and execute the global Regulatory Chemistry, Manufacturing and Controls strategy for Biogen’s small molecule portfolio

Job Summary

  • As Associate Director, Regulatory CMC Small Molecule Lead, you will shape and execute the global Regulatory Chemistry, Manufacturing and Controls strategy for Biogen’s small molecule portfolio.
  • Biogen offers a competitive compensation package including base salary, cash bonus, equity incentives, and a comprehensive benefits program supporting employees’ physical, financial, emotional, and social well-being.
  • Biogen fosters a culture of inclusion and belonging, emphasizing diversity and innovation while providing unparalleled opportunities for learning, growth, and impact.

Matching Summary

As Associate Director, Regulatory CMC Small Molecule Lead, you will shape and execute the global Regulatory Chemistry, Manufacturing and Controls strategy for Biogen’s small molecule portfolio.

Salary

Base: $155,000.00-$214,000.00; Bonus/Equity: Cash bonus and equity incentive opportunities; Benefits: Medical, Dental, Vision, Life insurance, Disability, Paid time off, 401(k) with match, Employee stock purchase plan, Tuition reimbursement

Skills & Requirements

Must-have

  • Regulatory CMC expertise
  • Global regulatory submissions
  • Cross-functional team leadership
  • ICH region registration procedures
  • Health Authority communication
  • CMC change management systems

Nice-to-have

  • Strategic thinking and problem-solving
  • Mentoring and coaching skills
  • Experience working across global time zones
  • Collaborative spirit
  • Matrixed environment adaptability

Key Requirements

  • Bachelor’s degree in Life Sciences or related field
  • Minimum 10+ years pharmaceutical industry experience
  • At least 7+ years in Regulatory CMC
  • Proven success authoring CMC submissions
  • In-depth knowledge of global regulations and ICH/GMP
  • Experience with regulatory authority interactions

Work Rights

Not specified

Tailored Resume

Cover Letter