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.
Management of regulatory data and documentation within relevant electronic systems, in support of new marketing authorization applications.
Variations Type IA, IB, II (including grouping and worksharing procedures) or equivalent procedures in accordance with national legislation.
Collaborate with cross‐functional teams to define and manage timelines for the preparation of regulatory submissions.
Contribute to the management of core dossiers, including gap analysis activities, to support registrations across multiple international markets, in collaboration with relevant departments.




Monitor legislation in force and assure regulatory compliance.
Provide regulatory assessment for new business opportunities.
Scientific degree.
Master in Regulatory Affairs (preferred).
Required Skills and Experience
More than 5 years of experience in Regulatory Affairs within multinational pharmaceutical firms (ideally at parent companies) or international regulatory consulting companies.
Experience with the EU Centralised and Decentralised Procedures.
Background in OTC product development and lifecycle management.
High level of autonomy in managing assigned activities.
In-depth knowledge of pharmaceutical legislation for medicinal products for human use and medical devices.
Experience in the use of electronic systems for the management of data and regulatory documents (RIMS, DMS, eCTD platform).
Flexibility and adaptability in a dynamic environment.
Required Languages
Fluent in English.

📌 Regulatory Specialist and Senior Specialist (Italia)
🏢 Recordati
📍 Italia