RegulatoryAffaiRegulatoryAffairs Associate - Fix-term contractrs Associate - Temporary
Business Area: Regulatory Affairs
Full-Time or Part-Time: Tempo pieno
Entry level
We are looking for a Regulatory Affairs Associate - Fixed-term contract 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.
New Marketing Authorisation Applications
Variations Type IA, IB, II (including grouping and worksharing procedures) or equivalent procedures in accordance with national legislation
Based on the products assigned, the Regulatory Affairs Associate will also:
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 the 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
At least 6 months/1 year of experience in Regulatory Affairs within multinational pharmaceutical firms (ideally at parent companies) or international regulatory consulting companies
In-depth knowledge of pharmaceutical legislation for medicinal products for human use
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
Gross Annual Salary starting from: 36,000 €
The salary indicated in this posting complies with local pay transparency regulations for Itali

Regulatory AffaiRegulatory Affairs Associate

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