JOB DESCRIPTION
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 worldwide work to discover and bring life-changing medicines to those in need, improve the understanding and management of disease, and give back to communities through philanthropy and volunteerism. We are committed to putting people first and making a positive impact. We seek individuals determined to improve lives globally.
Eli Lilly is seeking a Regulatory Affairs Scientist. This role will be part of the CMC European Global Regulatory Affairs organization, responsible for Drug Product registration activities within the Alcobendas production facility and with External Manufacturers. Location: Alcobendas site.
Main responsibilities:
* Develop global CMC regulatory strategies in collaboration with regulatory, MS&T, Quality, and project teams to ensure timely submission milestones and health authority approvals.
* Provide regulatory support for products and contract manufacturers by preparing and maintaining documentation needed for obtaining and maintaining Marketing Authorization.
* Lead the preparation, review, and finalization of CMC documents for global regulatory submissions, including manufacturing changes, new products, line extensions, or renewals.
* Ensure Regulatory Tools are accurately updated and used appropriately in a timely manner.
* Review changes and deviations, ensuring necessary regulatory activities are completed prior to implementation.
* Identify and escalate CMC regulatory issues affecting product submissions across regions.
* Provide regulatory guidance to Global Post Launch Teams, Change Control Boards, and Technical forums, implementing strategies for successful product updates.
* Ensure GMP documents comply with current regulatory commitments.
* Review and approve regulatory supporting documents.
Required qualifications:
* University Degree in a scientific field (Pharmacy, Biology, Chemistry, Biotechnology).
* 2-3 years of Regulatory CMC experience with Drug Products, including EU, US, and ICH guidelines.
* Excellent command of the English language.
* Strong communication skills and the ability to influence others.
* Willingness to travel as needed.
* Appreciation of cultural diversity.
* Attention to detail.
Lilly is committed to providing accommodations for individuals with disabilities during the application process. If you require assistance, please complete the accommodation request form. Lilly does not discriminate based on age, race, color, religion, gender, sexual orientation, gender identity, national origin, veteran status, disability, or any other protected status.
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