Regulatory Affairs Specialist – EU/UK/Switzerland

Language: English (Fluent/Proficient required)

Work Schedule: Hybrid – Minimum 3 days per week onsite in Siena, Italy

Project Overview

Lead and execute regulatory strategies, submissions, and maintenance activities for vaccine registrations across the EU, UK, and Switzerland.

Key Responsibilities

• Prepare, compile, and submit high-quality regulatory applications, including variations, renewals, and responses to health authority queries.
• Ensure regulatory dossier compliance across EU, UK, and Swiss markets.
• Provide regional regulatory expertise across global development, CMC, compliance, and labeling activities.
• Liaise with regulatory authorities and support agency interactions.
• Collaborate cross-functionally with QA, Medical, Pharmacovigilance (PV), Commercial Operations, and Business Development teams.

Must-Have Requirements

• Minimum 5+ years of Regulatory Affairs experience in the pharmaceutical or biotechnology industry.
• Degree in Biological Sciences, Pharmacy, an Allied Medical Discipline, or a related field.
• Strong experience with regulatory submissions and product registrations across the EU, UK, and Switzerland.
• Proven track record managing regulatory applications, variations, renewals, and health authority interactions.
• Full professional proficiency in English.

Preferred Qualifications

• Experience in vaccines and/or biologics.
• Hands-on experience with Veeva and regulatory application management systems.
• Advanced degree in a relevant discipline.
• Strong project management and stakeholder management skills.