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
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 ApplicationsLine-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
- 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
More than 5 years of experience in Regulatory Affairs within multinational pharmaceutical frims (ideally at "parent companies") or international regulatory consulting companies Experience with the EU Centralised xysqume and Decentralised Procedures Background in OTC product development and
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