Job Summary:
This is a 12 month fixed term position at Eli Lilly Cork. The CMC Pre-approval Principal Regulatory Scientist supports clinical trials and marketing authorization submission management processes.
The successful candidate will manage submission content for Drug Substance and Drug Product, and responses to questions in partnership with the GRA-CMC Regulatory Scientist.
The role involves tactical and operational direction to expedite CMC development of Lilly's portfolio and technical agenda by supporting clinical trial and market registration submissions.
Key responsibilities include planning and preparing submission content and responses to questions, managing internal requirements and documentation, developing regulatory strategies, and partnering with RDE CMC Regulatory Associates.
The ideal candidate will have a strong working knowledge of global regulations, guidelines and regulatory precedence coupled with a strong technical knowledge of CMC development and manufacturing processes.
They will also be able to create an environment that encourages open discussions on issues to achieve a robust outcome on project decisions, leverage internal forums to develop and share regulatory expertise, and communicate effectively to guide and influence within work groups.
Minimum qualification requirements include a Bachelor's degree in a science, engineering, or related field with 6 – 8 years experience in CMC regulatory or drug substance or drug product development, commercialization, manufacturing or quality.
Alternatively, a Master's degree in regulatory affairs or a science, engineering, or related field with 3 – 5 years experience may be considered.
Eli Lilly Cork offers a premium workspace with flexible hybrid working options, healthcare, pension and life assurance benefits, subsidized canteen, onsite gym, travel subsidies and on-site parking.
We are committed to diversity, equity and inclusion (DEI) and cater for all dimensions including ethnicities, nationalities, cultural backgrounds, generations, sexuality, visible and invisible disabilities and gender.
We partner with the Access Lilly initiative to make our physical and digital environment accessible and inclusive for all.
At Eli Lilly Cork, we value people who are determined to make life better for patients around the world and give our best effort to our work while putting people first.