Eli Lilly is seeking a Sr. Manager of Regulatory Affairs CMC to oversee new product registrations and lifecycle maintenance from a CMC perspective. The ideal candidate will possess extensive experience in drug development and regulatory affairs, particularly with a focus on China regulations
Job Summary
The role involves independently driving new product registrations and life-cycle maintenance from a CMC perspective for Eli Lilly's portfolio.
Candidates must possess deep technical expertise in CMC drug development science and the ability to interpret China regulatory guidelines.
The position requires active participation in shaping the regulatory environment through industry platforms like RDPAC and DIA.
Matching Summary
Match Score: 85
Eli Lilly is seeking a Sr. Manager of Regulatory Affairs CMC to oversee new product registrations and lifecycle maintenance from a CMC perspective. The ideal candidate will possess extensive experience in drug development and regulatory affairs, particularly with a focus on China regulations.
Skills & Requirements
Must-have
Master degree in pharmaceutical sciences
7+ years drug development experience
3+ years global pharma company experience
Full NDA/BLA project submission to approval
China regulations and ICH guidance knowledge
Nice-to-have
Experience with ADC, gene or cell therapy
Knowledge of FDA and EMA regulations
Experience with novel therapeutic modalities
Strong English communication skills
Ability to lead cross-functional teams
Key Requirements
Master degree in pharmaceutical or chemical sciences
At least 7 years experience in drug development
At least 3 years experience in global leading pharmaceutical company
Hands-on experience with full NDA/BLA projects
Familiarity with China regulations and ICH guidance