01 ott - Italia
464 Eli Lilly Italia
At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life‑changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, self‑less work—but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.
Contract Type: Fixed Term 12 months - Agency Contract Purpose The purpose of the Associate Regulatory Affairs role is to manage regulatory projects/processes/activities for new and existing products respecting European and Italian Law/Regulation and Eli Lilly Corporate/Eli Lilly Italia Policy and Standard Operating Procedures (SOPs).
Responsibilities Acting as a primary interface with the local regulatory authorities.
Maintaining Marketing Authorizations (i.e., renewals, variations, new indications, line extensions) Revision, translations, and preparation of labeling for drugs and medical devices (i.e., Summary Product Characteristics (SmPCs), Leaflets, Cartons, Labels, User manual). Submission to regulatory Authorities (Agenzia Italiana del Farmaco, AIFA, and Italian Ministry of Health) of any changes (technical/safety/efficacy) concerning the updating to registration dossier of Lilly products/devices. Responsible to communicate shortages of Lilly medicinal products to AIFA and to the European Medicines Agency (EMA). Responsible to manage/communicate Risk Management Plan/Risk Minimization activities and Dear Health Care Provider (DHCP) letter/Important Informative Note (NII) with AIFA. Providing the relevant information to the Global Regulatory Affairs-International (GRA-Intl) Scientists, performing relevant activities such as: a)
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