Undergraduate - Regulatory Affairs

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.

Job Title:

Undergraduate Regulatory Affairs

Organization Overview:

For more than 145 years Lilly has been committed to bringing life-changing medicines to those who need them, advancing the understanding and management of disease, and supporting communities where we live and work. We’re proud of our heritage, and at our manufacturing site in Kinsale, we value integrity, excellence, and respect for people. The planned undergraduate placement will be within the Regulatory Affairs Department in Eli Lilly Kinsale. Regulatory Affairs is core to delivering our product pipeline via management of global submissions for both New Chemical Entities (NCE’s) and New Molecular Entities (NME’s) in relation to drug substance manufactured at Kinsale. The Regulatory Department at Kinsale is also a leader in global post approval change management for commercial products, thus ensuring reliable supply and continuous improvement. 

Responsibilities:

To support members of the Regulatory Affairs Department with activities associated with the:

• Submission of new registrations and post approval changes, for the chemistry, manufacturing, and control (CM&C) information, to regulatory agencies worldwide for products manufactured at Kinsale
• Management of submission timelines, monitoring of approval status and communication of change status with QA and supply chain personnel (as appropriate)
• Compliance of GMP documents to regulatory commitments
• Maintenance of Regulatory Commitment Documents

Basic Requirements:

Required to complete an undergraduate placement as part of their degree in a related discipline such Pharmacy, Biological or Pharmaceutical Science

Additional Skills/Preferences:

The role is most suited towards a conscientious individual who has excellent verbal and written communication skills and, is fully proficient in using common Microsoft applications to create and present work. The successful applicant must have good organizational skills, with the ability to prioritize and work on their own initiative, both collaboratively as a team member and also on individual projects.

Additional Information:

Position location: The position is located at the Eli Lilly site in Kinsale Ireland. 4 days on site required.

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.