About Lilly
We unite caring with discovery to make life better for people around the world.
At Eli Lilly Cork, we are a global healthcare leader headquartered in Indianapolis, Indiana. Our talented diverse team of over 2000 employees across 60 nationalities delivers innovative solutions that add value across various Business Service functions.
Eli Lilly Cork offers a premium workspace across our campus in Little Island, complete with flexible hybrid working options, healthcare, pension and life assurance benefits, subsidised canteen, onsite gym, travel subsidies and on-site parking.
In-house People Development services, Educational Assistance, and our 'Live Your BEST Life' wellbeing initiatives enhance the career experience for our colleagues.
Career Purpose:
The Cork CMC Regulatory Scientist leads global marketing authorization submission management processes in partnership with the GRA-CMC Regulatory Scientist.
This role partners with GRA-CMC Regulatory Scientist to manage submission content for Drug Substance and Drug Product, and provides guidance on structure and content placement within CTD registration submissions.
The Cork CMC Regulatory Scientist provides tactical and operational direction to expedite CMC development of Lilly's portfolio and technical agenda by supporting market registration submissions, and post-approval submissions.
This involves networking with RDE CMC Regulatory Associates to ensure proper communication and adherence to workflows to deliver on time product lifecycle management.
Primary Responsibilities:
* Regulatory Expertise:
o 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.
o Partner with GRA-CMC Regulatory Scientists to manage outsourcing activities & contract manufacturers.
o Ensure successful preparation of CMC dossiers and variation packages to support product submissions.
o Develop, plan and execute appropriate regulatory strategies and on agreed-upon priorities through effective partnership with GRA-CMC Regulatory Scientists and other functional representatives.
* Lead, Influence, Partner:
o Create an environment within the Global Regulatory Area and across CMC teams that encourages open discussions on issues to achieve a robust outcome on project decisions.
o Leverage internal forums to continue to develop and share regulatory expertise to meet critical product registration timelines and electronic submission structure and content requirements.
o Communicate effectively to guide and influence within work group/function regarding life-cycle management processes.
Requirements:
* Minimum a college degree (BSc), ideally an advanced degree (MSc, PhD, PharmD preferred), in 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 / bio-pharmaceuticals.
* Strong knowledge of Manufacturing & Quality work processes as well as GMP compliance.
* Proven ability to effectively influence within and beyond the GRA organization.