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)
#J-*****-Ljbffr

📌 Regulatory Affairs Specialist (Milano)
🏢 Experteer Italy
📍 Milano