Regulatory Affairs Manager Greece Cyprus Malta
Core
Ensure compliant and timely regulatory lifecycle management of Takeda's product portfolio across Greece, Cyprus, and Malta, acting as the key contact for local Health Authorities.
Role type
Regulatory Affairs Manager
Builds
Product registrations, lifecycle activities, and market access for pharmaceutical products
Domain
Pharmaceuticals, EU and local regulatory affairs
Required skills
Regulatory lifecycle management, EU and local regulatory requirements knowledge, Health Authority liaison, regulatory submissions, change control processes, product information and labelling compliance, cross-functional collaboration
Preferred skills
Multinational pharmaceutical environment experience, promotional/medical material review, international team collaboration
Technologies
None stated
Responsibilities
Lead regulatory lifecycle management activities including new registrations, renewals, and variations; Manage national phases of European procedures; Assess local impact of global dossier updates; Ensure product information and labelling compliance; Coordinate regulatory translations; Build relationships with local Health Authorities; Support audits and inspections; Provide regulatory expertise to cross-functional teams
Seniority
Mid-level, hands-on IC