Regulatory Affairs Specialist

About This Role

This role is for a Regulatory Affairs Specialist to join the Regulatory Affairs department at the company's Verona office. The specialist will manage regulatory documentation, variations, renewals, and new registrations for medicines, ensuring compliance with national and European regulations.

Responsibilities

• Prepare regulatory documentation and support the management of variation, renewal, and new registration practices for authorized medicines through national and European procedures (MRP/DCP and Centralized), in compliance with current legislation
• Coordinate post-marketing activities, defining timelines for reviewing and implementing approved variations and initiating processes for updating authorized texts and related publications
• Manage the archiving of regulatory documentation according to company procedures
• Collaborate with key company functions, including Quality Assurance, Pharmacovigilance, Production, Supply Chain, and Marketing
• Update company regulatory databases and contribute to the implementation of new IT systems and platforms at national, European, and corporate levels
• Review labeling texts for Foods for Special Medical Purposes (FSMP) and food supplements, ensuring compliance with applicable regulations

Requirements

• Degree in scientific disciplines (Pharmaceutical Chemistry and Technology, Pharmacy, Chemistry, Biotechnology, or similar)
• At least 4-5 years of experience in Regulatory Affairs, preferably in the pharmaceutical sector
• Knowledge of national and European legislation applicable to medicines, medical devices, foods for special medical purposes, and food supplements
• Good knowledge of written and spoken English
• Familiarity with major IT tools and regulatory databases
• Excellent organizational skills, precision, and attention to detail
• Aptitude for teamwork and cross-functional collaboration

About the Company

Fresenius Kabi is a leading multinational company in infusion, transfusion, and clinical nutrition drugs and technologies, working daily to care for patients worldwide.