Associate Director, Regulatory Cmc Small Molecule Lead
Biogen
Baar, Switzerland
Global regcmc submissions
Regulatory cmc strategy
Health authority requirements
You will be responsible for leading cross-functional regulatory CMC activities to ensure timely preparation and delivery of high-quality regulatory submissions that support product development, registration, and lifecycle management
Job Summary
You will be responsible for leading cross-functional regulatory CMC activities to ensure timely preparation and delivery of high-quality regulatory submissions that support product development, registration, and lifecycle management.
This position requires a strategic thinker and strong communicator with deep regulatory CMC expertise who thrives in a global, matrixed environment.
As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact.
Matching Summary
You will be responsible for leading cross-functional regulatory CMC activities to ensure timely preparation and delivery of high-quality regulatory submissions that support product development, registration, and lifecycle management.
Skills & Requirements
Must-have
Global RegCMC submissions
Regulatory CMC strategy
Health Authority requirements
Global CMC regulations
Cross-functional leadership
Nice-to-have
Strategic thinker
Collaborative spirit
Pioneering spirit
Inclusion and belonging
Key Requirements
Bachelor’s degree in Life Sciences, Engineering, Biotechnology, or Pharmaceutical Science
Minimum 10+ years pharmaceutical industry experience
At least 7+ years in RegCMC
Proven success authoring and delivering CMC submissions
Experience with registration procedures in ICH regions
Direct communication with health authorities
In-depth knowledge of global regulations, ICH/GMP requirements