Associate Director, Regulatory Cmc Small Molecule Lead
Biogen
Baar, Switzerland
Global regcmc strategy
Lead cross-functional teams
Health authority interactions
You will play a pivotal role in shaping and executing the global Regulatory Chemistry, Manufacturing and Controls (RegCMC) strategy for Biogen’s small molecule portfolio
Job Summary
You will play a pivotal role in shaping and executing the global Regulatory Chemistry, Manufacturing and Controls (RegCMC) strategy for Biogen’s small molecule portfolio.
Lead cross-functional teams responsible for global RegCMC submissions (IND/IMPD/CTAs, NDAs/MAAs) and responses to Health Authority questions.
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 play a pivotal role in shaping and executing the global Regulatory Chemistry, Manufacturing and Controls (RegCMC) strategy for Biogen’s small molecule portfolio.
Skills & Requirements
Must-have
Global RegCMC strategy
Lead cross-functional teams
Health Authority interactions
CMC regulations
Small molecule products
Nice-to-have
Strategic thinker
Collaborative spirit
Global matrixed environment
Pioneering spirit
Inclusion and belonging
Key Requirements
Bachelor’s degree in Life Sciences or relevant Pharmaceutical Science
Minimum 10+ years pharmaceutical industry experience
At least 7+ years in RegCMC
Proven success authoring and delivering CMC submissions
Broad experience with registration procedures in ICH regions
In-depth knowledge of global regulations and ICH/GMP requirements