Overview

In this role you drive regulatory affairs for Lilly products, managing submissions and lifecycle activities across EU procedures. You will collaborate with local and European teams to ensure compliant market access and packaging materials, while shaping regulatory strategies. You’ll navigate health authority interactions and stay ahead of evolving legislation to support timely patient access. This is a mission-driven, cross-functional role at a global leader, offering impact across products and markets.

Compensaciones / Incentivos

- pension plan
- healthcare benefits
- life insurance
- vacation benefits
- well-being benefits
- annual bonus eligibility

Responsabilidades

- Manage preparation, submission and maintenance of marketing authorisations via MRP, DCP, and Centralised procedures
- Maintain smooth interaction with health authorities
- Create and review medicinal product packaging materials
- Coordinate with various company departments




- Use and maintain regulatory databases
- Implement effective regulatory strategies and monitor them
- Collaborate with local and European teams across departments
- Manage regulatory procedures and internal policies
- Stay informed on applicable legislation and analyze new European and local regulations
- Participate in professional technical associations

Requisitos principales

- Bachelor’s degree in Health Sciences
- 5 years’ experience in a pharmaceutical company or at the AEMPS
- High level of English (C1-Advanced)
- Specialised training in European procedures for the registration and regulation of medicinal products

- Proactive
- Excellent communication skills
- Problem solving
- Marketing authorisation management
- Regulatory strategy implementation
- Health authority interaction

📌 Especialista en Asuntos Regulatorios (Madrid)
🏢 Eli Lilly
📍 Madrid