REGULATORY AFFAIRS SPECIALIST

Experteer Overview

In this role you will manage regulatory activities for SPC medicinal products for human use across EU and non‑EU regions. You will prepare and submit regulatory documentation, maintain data in electronic systems, and support lifecycle management for multiple markets. You’ll work with cross‑functional teams to align timelines, manage core dossiers, and interact with regulatory authorities to ensure compliance. The opportunity offers exposure to global regulatory strategies and the chance to influence product registrations and market access.Retribuzione / Benefits

• Prepare, review and submit regulatory documentation to Health Authorities
• Manage regulatory data in electronic systems
• Support new Marketing Authorisation Applications, line‑extensions, renewals and variations
• Coordinate MA transfers, notifications, sunset clause exemptions
• Review and approve printed materials and artworks
• Request Notified Body Opinions
• Define regulatory activity plans and related costs
• Collaborate with cross‑functional teams to manage submission timelines
• Contribute to core dossiers with gap analyses for multiple international markets
• Coordinate with affiliates, licensees and consultancies
• Maintain relations with Regulatory Authorities
• Monitor legislation to assure regulatory compliance
• Provide regulatory assessment for new business opportunities

Responsabilità

• More than 5 years of experience in Regulatory Affairs in multinational pharmaceutical firms or international regulatory consulting
• Experience with EU Centralised and Decentralised Procedures
• Background in OTC product development and lifecycle management
• High autonomy in managing assigned activities
• Fluent in English
• Master in Regulatory Affairs (preferred)
• Scientific Degree
• Experience with electronic systems for regulatory data (RIMS, DMS, eCTD platform)

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