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Regulatory Affairs Director

2 weeks ago

Cork, Cork, Ireland Eli Lilly And Company Full time
About the Role

We are seeking a highly skilled and experienced Associate Director to join our Explor&D Regulatory Affairs team. As a key member of the team, you will be responsible for providing strategic, tactical, and operational direction and support to deliver global regulatory strategies from candidate selection to clinical proof of concept for assigned assets.

Key responsibilities include managing all regulatory activities (strategy and implementation) for assigned programs across different therapeutic areas and geographies, with focus on US, Canada, UK, EU, and Australia. You will partner across functions, Sponsors, vendors, and health authorities to construct plans to test key scientific hypotheses, discharge risks regarding asset safety and efficacy, and enable effective decision-making related to asset development.

This role requires a strong understanding of global clinical drug development regulations, procedures, and practices, with a focus on US, Canada, UK, EU, and Australia. The successful candidate will have demonstrated leadership abilities/behaviors, particularly entrepreneurial mindset, strategic thinking, and teamwork; able to adapt to diverse interpersonal styles.