Director of Global Regulatory Science (Hybrid)

Posted 3 days 8 hours ago by 527 Eli Lilly Cork Limited

Permanent
Full Time
Other
Cork, Cork, Ireland
Job Description

Eli Lilly Cork is seeking an Associate Director/Director, Global Regulatory Affairs (GRS) to lead US regulatory strategy for assigned products, aligning local plans with global plans and FDA requirements. This fixed-term 12-month contract offers a leadership role within a diverse regulatory team.

The role includes preparing regulatory submissions (INDs, NDAs, BLAs), leading FDA interactions, mentoring staff, and partnering with global teams to drive regulatory excellence and compliant labelling.