Associate Director, Regulatory Cmc Small Molecule Lead

Biogen

Baar, Switzerland
Regulatory cmc submissions management
Global cross-functional team leadership
Regulatory strategy implementation
As Associate Director, Regulatory CMC Small Molecule Lead, you will play a pivotal role in shaping and executing 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 play a pivotal role in shaping and executing the global Regulatory Chemistry, Manufacturing and Controls strategy for Biogen’s small molecule portfolio.
  • This position requires a strategic thinker and strong communicator with deep regulatory CMC expertise who thrives in a global, matrixed environment.
  • Biogen is committed to building on a culture of inclusion and belonging that reflects the communities where they operate and the patients they serve.

Matching Summary

As Associate Director, Regulatory CMC Small Molecule Lead, you will play a pivotal role in shaping and executing the global Regulatory Chemistry, Manufacturing and Controls strategy for Biogen’s small molecule portfolio.

Skills & Requirements

Must-have

  • Regulatory CMC submissions management
  • Global cross-functional team leadership
  • Regulatory strategy implementation
  • Health Authority communication
  • Compliance with global CMC regulations
  • Project management skills

Nice-to-have

  • Strategic thinking and problem solving
  • Mentoring and coaching skills
  • Experience working across global time zones
  • Collaborative spirit
  • Strong written and verbal communication

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
  • Experience with ICH region registration procedures
  • In-depth knowledge of global regulations and ICH/GMP
  • Experience communicating with health authorities

Work Rights

Not specified

Tailored Resume

Cover Letter