Regulatory Affairs Specialist
Pubblicato il 01-08-2026 - Biotecnologie - Farmacia - Chimica in Italia
At Recordati, we are united by a clear purpose: unlocking the full potential of life. With a century of history behind us, we are building the next chapter of our journey, continuing to grow while keeping patients at the centre of all we do.
What drives us is a shared belief that health, and the opportunity to live life to the full, should be within reach for everyone. This brings energy to our work, shaping how we support each other and show up every day. Our values – Better Together, Never Settle and Always Deliver – reflect this mindset, helping us to keep improving and make a meaningful difference.
Above all, these values bring to life our promise to everyone at Recordati, you can unlock your full potential. We know that people thrive when they can be themselves, are trusted and supported, and are given the opportunity to grow and make a meaningful contribution.
Are you ready to unlock your full potential?
Job Purpose
We are looking for a Regulatory Affairs Specialist to join the International Corporate Regulatory Affairs team,
responsible for managing regulatory activities for SPC medicinal products for human use. Responsibilities include obtaining and maintaining marketing authorizations in the European Union (through CP/MRP/DCP) as well as supporting regulatory activities in various non-EU regions, including Africa, Asia Pacific, CENAM, CSI, LATAM, MENA.
Key Responsibilities
New Marketing Authorisation Applications
Line-extension,
Renewal of Marketing Authorizations
Variations Type IA, IB, II (including grouping and worksharing procedures) or equivalent procedures in accordance with national legislation
Marketing Authorization transfers
Notification of start and end of marketing
Requests for Sunset Clause exemptions
Review and approval of printed materials (artworks and mock-ups)
Request for Notified Body Opinions
Based on the products assigned, the Regulatory Affairs Specialist will also:
Define regulatory activity plans and related costs
Collaborate with cr