Job Title: Regulatory Scientist GRA-CMC
About the Role:
The Cork CMC Regulatory Scientist leads, in partnership with the GRA-CMC Regulatory Scientist, various aspects of global marketing authorization submission management processes. They provide regulatory support for existing Drug Substances and Drug Products by preparing and maintaining the appropriate regulatory submission documentation needed to obtain & maintain marketing authorizations.
Key Responsibilities:
* Prepare and maintain regulatory submission documentation for marketing authorizations.
* Partner with GRA-CMC Regulatory Scientists to manage outsourcing activities & contract manufacturers.
* Ensure successful preparation of CMC dossiers and variation packages to support product submissions.
* Provide regulatory leadership and support for products listed as primary responsibilities.
* Develop, plan, and execute appropriate regulatory strategies and priorities through effective partnership with GRA-CMC Regulatory Scientists and other functional representatives.
Requirements:
* Minimum a college degree (BSc), ideally an advanced degree (MSc, PhD, PharmD preferred) in a related biological and life science field.
* Solid regulatory experience in either a pharmaceutical or biotech setting.
* Strong knowledge of regulatory and compliance guidelines within pharmaceuticals / biopharmaceuticals.
* Strong knowledge of Manufacturing & Quality work processes as well as GMP compliance.
* Proven ability to effectively influence within and beyond the GRA organization.
Benefits:
Lilly offers a premium workspace, flexible hybrid working options, healthcare, pension, and life assurance benefits, subsidized canteen, onsite gym, travel subsidies, and on-site parking. In-house People Development services, Educational Assistance, and 'Live Your BEST Life' wellbeing initiatives enhance the career experience for our colleagues.
The estimated salary for this role is around $120,000 - $160,000 per year, depending on location and experience.