Senior Regulatory Affairs Administrator - Central Regulatory Affairs (CRA)
Core
Support regulatory activities across a portfolio of pharmaceutical products throughout Europe, ensuring compliance with European and local regulatory requirements.
Role type
Senior Regulatory Affairs Administrator (Central Regulatory Affairs)
Builds
Marketing authorisations and regulatory compliance for pharmaceutical products
Domain
Pharmaceuticals / Healthcare / Life Sciences
Required skills
Regulatory Affairs knowledge, administrative experience in regulated environments, strong organisational skills, attention to detail, fluent English (written and spoken)
Preferred skills
Experience in pharmaceuticals, healthcare, life sciences, or a regulated environment
Technologies
Regulatory Information Management (RIM) systems
Responsibilities
Assist with post-approval submissions including variations, renewals, and regulatory notifications; Coordinate administrative and compliance activities to support the maintenance of marketing authorisations; Maintain and update Regulatory Information Management (RIM) systems and databases; Work closely with local affiliate teams on regulatory and operational activities; Support regulatory fee processing, purchase orders, and other administrative tasks; Collaborate with cross-functional teams to ensure timely delivery of regulatory objectives
Seniority
Senior, hands-on IC