Associate Director of Regulatory Excellence
2 days ago
We are seeking an experienced Associate Director of Regulatory Excellence to join our team at Eli Lilly and Company. This role is responsible for leading the development and implementation of regulatory strategies for assigned products, ensuring compliance with all applicable regulations and internal quality systems.
The ideal candidate will have a Bachelor's degree in a scientific or health sciences discipline and minimum 10 years of experience in regulatory affairs and/or drug development. Knowledge of local/regional regulatory procedures and practices is essential, as well as awareness of evolving regulatory reform initiatives.
This role requires demonstrated leadership skills, ability to assess and manage risk in a highly regulated environment, and the ability to find solutions and alternatives through teamwork embracing diversity, equity and inclusion resulting in positive business outcomes.
Key Responsibilities:
- To lead the development and implementation of regulatory strategies for assigned products, ensuring compliance with all applicable regulations and internal quality systems.
- To provide strategic guidance and support to cross-functional teams in delivering high quality and efficient regulatory submissions, approvals, and labelling for assigned products.
- May perform regulatory evaluations of external business opportunities, as requested by management, and may effectively manage alliance/CRO relationships in regulatory area.
Estimated Salary: $160,000 - $200,000 per year, depending on location and experience.
About Us: Eli Lilly and Company is a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world 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 and volunteerism.
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