Intern - Regulatory Delivery Excellence (RDE)
Lilly
At 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. We’re looking for people who are determined to make life better for people around the world.
Intern - Regulatory Delivery Excellence (RDE)
Start date: January 2026
End date: August 2026
Hybrid role requiring the successful candidate to be on site 10 days per month in Little Island, Cork.
Eli Lilly Cork is made up of 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. 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. Inhouse People Development services, Educational Assistance, and our ‘Live Your BEST Life’
wellbeing initiatives are just some of the holistic benefits that enhance the career experience for our colleagues.
Eli Lilly Cork is committed to 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, embRACE, LGBTQ+ & Ally and GIN-Gender Inclusion Network. EnAble, our pillar for people with disabilities and those that care for them, partners with the Access Lilly initiative to make our physical and digital environment accessible and inclusive for all. Together they are committed to promoting awareness to create a disability confident culture both at Eli Lilly Cork and beyond.
Come join our team - Be Creative, Be an Innovator, and most of all, Be Yourself!
The CMC (Chemistry, Manufacturing, and Controls) Regulatory Intern supports the RDE team on the completion of Module 1 and any regional information for all submissions where CMC support is required, e.g., new product submissions, product renewal submissions, post-approval changes, single product and multi product manufacturing site registrations renewals etc. This also includes the preparation and appropriate set-up of CMC documents in the Lilly regulatory information management system.
**Responsibilities:**
+ Supports the RDE teams with collating Module 1 documents required for CMC submissions (new product, variations, renewals, site registrations etc.).
+ Attends weekly meetings for products, site registrations and renewals.
+ Co-ordinates global registration activities by requesting and preparing documents such as Certificates of Pharmaceutical Products (CPPs), Certificates of Analysis (CoAs), Ministry of Health GMP certificates.
+ Organizes Regulatory letters and declarations to be sent to global health authorities.
+ Runs weekly metrics and adhoc support requests on our Regulatory Information (RIM) system.
**Requirements:**
+ Currently enrolled in 3rd level education and ready to pursue student placement as part of a masters program.
+ Self-motivated individual with demonstrated ability to identify issues and solutions for a positive result.
+ Ability to prioritize workload and effective interpersonal skills; can work as part of a team.
+ Strong computer skills with proficiency in MS applications including MS Word, and Excel.
Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form ( https://careers.lilly.com/us/en/workplace-accommodation ) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.
Lilly does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.
\#WeAreLillyUKandIreland
At Lilly we strive to ensure our employees are part of a team that cares about them and our shared purpose of making life better for those around the world. How do we do this? We continue to look for ways to include, innovate, accelerate and deliver while maintaining integrity, excellence and respect for people. We hope that you seek to join us on our journey as we create medicine and deliver improved outcomes for patients across the globe!
\#WeAreLilly
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