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
Deliverable
client delivery
Required skills
Regulatory affairs knowledge, administrative experience, attention to detail, organisational skills, stakeholder management, fluent English
Preferred skills
Experience in pharmaceuticals, healthcare, life sciences, or regulated environments
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; Support regulatory fee processing, purchase orders, and other administrative tasks; Work closely with local affiliate teams on regulatory and operational activities; Collaborate with cross-functional teams to ensure timely delivery of regulatory objectives
