Global Regulatory Manager

6 days ago


Cork, Cork, Ireland Eli Lilly And Company Full time

Eli Lilly And Company is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. As a member of our team, you will have the opportunity to contribute to our mission of making life better for people around the world.

We are seeking an experienced Regulatory Scientist to join our team in Cork. As a CMC Regulatory Expert, you will be responsible for providing regulatory support for existing Drug Substances and Drug Products by preparing and maintaining the appropriate regulatory submission documentation needed to obtain & maintain marketing authorizations.

You will work closely with GRA-CMC Regulatory Scientists to manage outsourcing activities & contract manufacturers, ensure successful preparation of CMC dossiers and variation packages to support product submissions, and provide regulatory leadership and support for products listed as the primary responsibilities.

A key aspect of this role is developing, planning and executing appropriate regulatory strategies and on agreed-upon priorities through effective partnership with GRA-CMC Regulatory Scientists and other functional representatives, such as TS/MS (process and technology transfers), manufacturing, quality control and quality assurance.



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