Eli Lilly Cork is seeking an Associate/Sr. Associate for Regulatory CMC within Regulatory Delivery Excellence, focusing on global marketing authorization submission management. The position offers a hybrid work model and a range of benefits while emphasizing diversity, equity, and inclusion within its workforce
Job Summary
The Associate, Regulatory CMC, Regulatory Delivery Excellence (RDE) leads, in partnership with the GRA-CMC RA Scientists, the various aspects of global marketing authorization submission management processes.
Eli Lilly Cork offers a premium workspace across our campus in Little Island, complete with flexible hybrid working options, healthcare, pension and life assurance benefits, subsidised canteen, onsite gym, travel subsidies and on-site parking.
The Associate, Regulatory CMC works within regulations to expedite the registration and lifecycle maintenance of products.
Matching Summary
Match Score: 85
Eli Lilly Cork is seeking an Associate/Sr. Associate for Regulatory CMC within Regulatory Delivery Excellence, focusing on global marketing authorization submission management. The position offers a hybrid work model and a range of benefits while emphasizing diversity, equity, and inclusion within its workforce.
Skills & Requirements
Must-have
CMC submission management
ICH CTD knowledge
electronic submission regulations
regulatory requirement assessment
project management
communication with affiliates and scientists
Nice-to-have
Be Creative
Be an Innovator
Be Yourself
holistic benefits
diversity, equity and inclusion
Key Requirements
Bachelor’s Degree in a scientific or health sciences discipline
Knowledge of pharmaceutical drug development
Industry-related experience
Knowledge of Agency submission procedures
Knowledge of emerging submission electronic standards