Regulatory Affairs Specialist

About the role

Lilly is looking for a Regulatory Affairs Specialist in Alcobendas. The role manages the preparation, submission and maintenance of marketing authorisations for products registered under the Mutual Recognition, Decentralised and Centralised procedures, and keeps close contact with health authorities. It involves coordination with company departments, use of regulatory databases and continuous review of European and local legislation.

Key responsibilities

• Prepare, submit and maintain marketing authorisations under the Mutual Recognition, Decentralised and Centralised procedures
• Maintain smooth, ongoing interaction with health authorities
• Create and review medicinal product packaging materials
• Coordinate with the various company departments involved
• Use and maintain regulatory databases
• Implement effective regulatory strategies and monitor them
• Collaborate closely with departments at local and European level
• Manage and implement regulatory procedures and internal policies
• Keep up to date with applicable registration legislation and analyse new European and local laws
• Take part as a member of professional technical associations

Required profile

• Bachelor's degree in Health Sciences
• 5 years' experience in a pharmaceutical company or at the AEMPS
• High-level English (C1-Advanced or equivalent)
• Proactive, with excellent communication skills, problem-solving ability, teamwork and strong organisation and attention to detail

Preferred requirements

• Specialised training in European procedures for the registration and regulation of medicinal products

What we offer

• Salary range of 40,478 to 59,368 EUR depending on education, experience, skills and location
• Possible company bonus for full-time equivalent employees
• Benefits programme including pension plan, vacation, healthcare, flexible benefits, life insurance, time off and well-being benefits