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.
This position requires a strategic thinker and strong communicator with deep regulatory CMC expertise who thrives in a global, matrixed environment.
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, 401(k) with match, ESPP, Tuition reimbursement
Skills & Requirements
Must-have
Global RegCMC strategy
Small molecule portfolio
Lead cross-functional teams
Prepare regulatory submissions
Health Authority interactions
CMC regulations
ICH/GMP requirements
Nice-to-have
Strategic thinker
Strong communicator
Collaborative spirit
Pioneering spirit
Inclusion and belonging
Key Requirements
Bachelor’s degree in Life Sciences, Engineering, Biotechnology, or relevant Pharmaceutical Science
Minimum 10+ years relevant experience
At least 7+ years in RegCMC
Proven success authoring and delivering CMC submissions
Broad experience with registration procedures in ICH regions