Regulatory Affairs Specialist — EU Pharma Impact

Eli Lilly and Company; Alcobendas; On-site; EUR 40,000 - 59,000; Full time

Job summary

Eli Lilly and Company is seeking a Regulatory Affairs professional in Madrid to manage preparation, submission and maintenance of marketing authorisations for products under MR, DCP and Centralised procedures. The role involves ongoing interactions with health authorities and cross‑department collaboration to ensure compliant packaging and documentation.

The candidate will possess a Bachelor’s degree in Health Sciences, 5 years’ pharmaceutical experience, and a high level of English (C1).

Qualifications

• Bachelor’s degree in Health Sciences required.
• High level English (C1-Advanced or equivalent) is required.
• 5 years’ experience in a pharmaceutical company or at the AEMPS is required.

Responsibilities

• Manage the preparation, submission and maintenance of marketing authorisations for products under MR, DCP and Centralised procedures.
• Interact with health authorities to ensure smooth regulatory processes.
• Create and review medicinal product packaging materials.
• Coordinate with various company departments involved.
• Use and maintain regulatory databases.
• Implement and monitor effective regulatory strategies across local and European levels.
• Manage regulatory procedures and internal policies.

Skills

English (C1-Advanced)

Education

Bachelor’s degree in Health Sciences

Job description

Eli Lilly and Company is seeking a Regulatory Affairs professional in Madrid to manage preparation, submission and maintenance of marketing authorisations for products under MR, DCP and Centralised procedures. The role involves ongoing interactions with health authorities and cross‑department collaboration to ensure compliant packaging and documentation.

The candidate will possess a Bachelor’s degree in Health Sciences, 5 years’ pharmaceutical experience, and a high level of English (C1).