Regulatory Affairs Executive - Central Regulatory Affairs (CRA), Europe
Core
Manage regulatory activities for a portfolio of pharmaceutical products across Europe, supporting product registrations, lifecycle management, and regulatory compliance.
Role type
Regulatory Affairs Executive (Central Regulatory Affairs)
Builds
Regulatory applications, variations, renewals, and lifecycle management activities for pharmaceutical products
Domain
Healthcare / Pharmaceuticals / Europe
Required skills
Regulatory affairs experience, knowledge of European regulatory procedures, post-approval lifecycle management, database management, stakeholder management, regulatory authority interaction, monitoring regulatory developments
Preferred skills
Master's qualification in Regulatory Affairs
Technologies
Regulatory databases
Responsibilities
Manage regulatory activities for a portfolio of pharmaceutical products across Europe; Prepare and submit regulatory applications, variations, renewals, and other lifecycle management activities; Support new product registrations through European and national regulatory procedures; Collaborate with European affiliate teams to ensure successful implementation of regulatory strategies; Maintain regulatory databases and documentation to ensure ongoing compliance; Support interactions with regulatory authorities and contribute to responses to health authority queries; Monitor regulatory developments and assess their impact on the product portfolio
Seniority
Mid-level, hands-on IC