Regulatory Affairs Specialist
Core
Manage regulatory submissions and lifecycle activities for a generic pharmaceutical portfolio across European markets.
Role type
Regulatory Affairs Specialist
Builds
Marketing Authorisation Applications (MAAs) and compliant product portfolios for European tender markets
Domain
Pharmaceuticals (Generic) / European Regulatory Affairs
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Regulatory submissions management, Marketing Authorisation Application (MAA) coordination, eCTD documentation, EU pharmaceutical legislation knowledge, ICH guidelines, CTD/eCTD, CMC documentation, generic pharmaceuticals experience, decentralized procedures
Preferred skills
CMC documentation, generic pharmaceuticals experience, decentralized procedures, Swedish language, Spanish language
Technologies
CESP, eCTD
Responsibilities
Manage regulatory submissions from preparation through approval, Coordinate Marketing Authorisation Applications (MAAs) and lifecycle management activities, Prepare and compile regulatory documentation including responses to health authority questions, Manage eCTD documentation and electronic submissions via CESP, Coordinate national phase activities including product information translations and artwork updates, Ensure regulatory databases are maintained and commitments are fulfilled, Monitor European regulatory requirements and assess impact on portfolio, Collaborate with Supply Chain, Quality, Artwork and external authorities, Contribute to continuous improvement of regulatory processes
Seniority
Mid-level, hands-on IC
