This position is responsible for leadership of a North America Regulatory CMC (Chemistry, Manufacturing & Controls) team. This team is responsible for management of global CMC products with a focus on North American CMC Regulatory matters - develop regulatory strategy, oversee submission preparation and meet the reporting requirements for the registration/approval of new animal drug with global regulatory agencies. This position will help drive the Global CMC Regulatory strategy and serve as a member of the CMC Lead Team while also helping develop the NA Regulatory CMC team. This position also executes CMC regulatory functions necessary to provide supplements/variations, renewals, and annual reporting requirements for approved products, when needed.
Provide CMC Regulatory advice on submission strategy and tactics for execution of lifecycle submissions, with a diverse regulatory lens (i.e. USDA, CVM-FDA, MHRA etc.)
Develop local talent to sustain local & global competitiveness. This includes identifying individuals with leadership potential, providing mentoring and enrichment opportunities consistent with succession planning.
Work with the CMC Regulatory Lead Team to help set and drive the strategy and efficiency of the Global Regulatory CMC department
Work in partnership with global stakeholders across Elanco, including Global Regulatory Affairs, Pharmaceutical & Vaccine Development, Global Marketing and M&Q
Project manage timely submission of pre & post approval CMC documentation
Coordinate assembly and / or generate documentation of submission-ready components to support lifecycle submissions
Review and approve regulatory CMC documents to ensure compliance
Gain cross-functional approval for delivery of the documentation to Global Regulatory Affairs for worldwide use in regulatory submissions
Provide Regulatory Intelligence to support the operational and tactical regulatory CMC contribution and direction to Elanco product and project teams in support of products throughout the life cycle.
Comply with all company local and global policies including Quality frameworks, Code of Conduct, Corporate Citizenship, anti-discrimination, harassment, and health, safety and environment (HSE) policies.
Perform any other duties or serve in such other capacity as may be determined by Company management.
Internal Number: 50594
About Eli Lilly & Company
Company Overview At 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 39,000 employees worldwide 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. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.