Regulatory AffaiRegulatory Affairs Associate

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

JOB PURPOSE

We are looking for a Regulatory Affairs Associate - Fix-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

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 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 the regulatory compliance
• Provide regulatory assessment for new business opportunities

REQUIRED EDUCATION

• Scientific Degree
• Master in Regulatory Affairs (preferred)

REQUIRED SKILLS AND EXPERIENCE

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