Regulatory AffaiRegulatory Affairs Associate

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7fi5oz

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 authorisations 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
The candidate will be responsible for the preparation, review and submission of regulatory documentation to Health Authorities, as well as for the management of regulatory data and documentation within relevant electronic systems, in support of:
New Marketing Authorisation Applications
Line‐extension
Renewal of Marketing Authorisations
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 the regulatory compliance
Provide regulatory assessment for new business opportunities
Required Education
Scientific Degree
Master in Regulatory Affairs (preferred)
Required Skills And Experience
At least 6 months/1 year of experience i

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7fi5oz