Regulatory AffaiRegulatory Affairs Associate

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7dhb80

RegulatoryAffaiRegulatoryAffairs Associate - Fix-term contractrs Associate - Temporary

ID: 2687

Date of Posting: Jun 25, 2026

Business Area: Regulatory Affairs

Job Type: Direct Employee

Territory:

Full-Time or Tempo parziale: Full Time

Seniority: Entry level

Job Purpose

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.

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)

Based on the products assigned, the Regulatory Affairs Associate will also:
- Define regulatory activity plans and related costs
- 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
- Coordinate with the group's affiliates, licensees and consultancy companies
- Maintain relations with the Regulatory Authorities
- Monitor the legislation in force and assure regulatory compliance
- Provide regulatory assessment for new business opportunities

Required Education
- Scientific Degree
- Master in Regulatory Affairs (preferred)

Required Skills and

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7dhb80