Associate Director Regulatory Strategy
3 days ago
Our mission at Eli Lilly and Company is to unleash our capabilities and know-how to accelerate the science of biotech collaborators. Through our unique model, we provide knowledge and services to enable our collaborator's programs. This role plays a critical part in ensuring Lilly is networked with the brightest scientific minds worldwide.
As an Associate Director in ExploR&D Regulatory Affairs, you will be responsible for 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.
Key Responsibilities:
- Collaborate to develop and initiate effective regulatory strategies, focused on preparing CTA/INDs to support Phase 1 and 2 clinical development of externally owned assets.
- Provide guidance on appropriate nonclinical, toxicology, and CMC requirements for CTA/IND submission.
- Advise on dose selection, study participants, and clinical protocol designs, focusing on safety stopping rules and pharmacovigilance oversight.
Experience in working with cross-functional teams across multiple therapeutic areas is highly valued. You will partner across functions, Sponsors, vendors, and health authorities to construct plans to test key scientific hypotheses and discharge risks regarding asset safety and efficacy.
The successful candidate will have a Bachelor's degree in a scientific or health sciences discipline, with industry-related experience in regulatory affairs and/or drug development for at least 5 years. Strong communication and interpersonal skills are essential, with the ability to articulate complex concepts across various audiences.
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Cork, Cork, Ireland Eli Lilly And Company Full timeAt Lilly, we unite caring with discovery to make life better for people around the world.We are a global healthcare leader headquartered in Indianapolis, Indiana.Our employees work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy...