Associate Regulatory CMC Specialist
4 days ago
Eli Lilly and Company is a global leader in the healthcare industry, dedicated to making life better for people around the world. Our mission is to unite caring with discovery, and we are committed to improving human health through innovative medicines and solutions. We strive to be a workplace where everyone feels valued, respected, and empowered to contribute their best work.
This role plays a critical part in our commitment to delivering high-quality medicines and solutions to patients globally. As an Associate, Regulatory CMC, you will be responsible for leading the preparation of global marketing authorization submissions, ensuring compliance with regulatory requirements, and collaborating with cross-functional teams to drive business success. You will also be expected to stay up-to-date with evolving regulatory standards and guidelines to ensure our submissions meet the highest standards of quality and compliance. Your contributions will have a direct impact on the lives of millions of patients worldwide, and we invite talented individuals to join us in this journey.
Key Responsibilities
- Develop and implement submission plans to support clinical studies and manufacturing process changes.
- Collaborate with GRA-CMC Scientists to prepare and publish submission content.
- Analyze and respond to Lilly affiliate inquiries and requests.
- Apply knowledge of regulatory precedents and agency standards to ensure compliance and quality in submission processes.
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