Regulatory Specialist (San Sebastián de los Reyes)

Regulatory Specialist (San Sebastián de los Reyes)

02 oct
|
Eli Lilly
|
San Sebastián de los Reyes

02 oct

Eli Lilly

San Sebastián de los Reyes

Research & DevelopmentPosted Date: 2026-09-28At Lilly, the work is demanding because patients are waiting. 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, selfless work—but it’s work worth doing. ResponsibilitiesManage the preparation, submission and maintenance of marketing authorisations for products registered under the Mutual Recognition, Decentralised and Centralised procedures.Smooth and ongoing interaction with the health authorities.Creation and review of medicinal product packaging materials.Coordination with the various company departments involved.Use and maintenance of regulatory databases.Implementation of effective regulatory strategies and monitoring of these.Close interaction and collaboration with various departments within the company at both local and European levels.Continuous review of new European and local legislation.



Minimum requirementsBachelor’s degree in Health Sciences5 years’ experience in a pharmaceutical company or at the AEMPSHigh level of English (C1-Advanced or equivalent)Preferred requirementsSpecialised training in European procedures for the registration and regulation of medicinal productsAdditional InformationThe adecuado candidate will be proactive, with excellent communication skills, the ability to solve problems and work as part of a team, and a strong sense of organisation and attention to detail.The anticipated wage for this position is 4 - 4Full-time equivalent employees may also be eligible for a company bonus (depending, in part, on company and individual performance). WeAreLillySkillsmarketing authorisation managementregulatory strategy implementationhealth authority interactionmedicinal product packaging reviewregulatory database managementlegislation analysiseuropean medicinal product regulationsintern

📌 Regulatory Specialist (San Sebastián de los Reyes)
🏢 Eli Lilly
📍 San Sebastián de los Reyes

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