About 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 employees around the world 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.
Eli Lilly Cork
We have a talented diverse team of over 2000 employees across 60 nationalities who deliver innovative solutions that add value across a variety of Business Service functions including Finance, Information Technology, Medical, Clinical Trials and more.
We offer 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.
Career Benefits
* In-house People Development services
* Educational Assistance
* 'Live Your BEST Life' wellbeing initiatives
Diversity, Equity and Inclusion (DEI)
We cater for all dimensions ensuring inclusion of all ethnicities, nationalities, cultural backgrounds, generations, sexuality, visible and invisible disabilities and gender, with four pillars: EnAble, Age & Culture, LGBTQ+ and GIN-Gender Inclusion Network.
The Role: Cork CMC Regulatory Scientist
The Cork CMC Regulatory Scientist leads, in partnership with the GRA-CMC Regulatory Scientist, the various aspects of global marketing authorization submission management processes.
Responsibilities
1. 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.
2. 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.
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.