Regulatory Affairs Specialist

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7gbk3k

JOB PURPOSE

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.

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)
• Request for Notified Body Opinions
Based on the products assigned, the Regulatory Affairs Specialist 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

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7gbk3k