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 compliance with health authorities.
Role type
Regulatory Affairs Executive (Central Regulatory Affairs)
Builds
Regulatory submissions, lifecycle management activities, and compliance documentation for pharmaceutical products
Domain
Healthcare / Pharmaceuticals / Europe
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
European regulatory procedures knowledge, post-approval lifecycle management, regulatory application preparation, database management, stakeholder collaboration, health authority interaction, regulatory trend monitoring
Preferred skills
Master's degree 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
