Teams at Orion Corporation

Prepare, review, and maintain pharmaceutical and quality regulatory dossiers, variations, amendments, annual reports, renewals, and responses to regulatory deficiencies under EU requirements. Classify regulatory changes, maintain records and internal systems, collaborate with departments and partners, meet deadlines, and support regulatory capability development. The role requires international pharmaceutical regulatory affairs experience, EU and ICH knowledge, strong English communication, and a pharmacy or chemistry degree.

Manage and coordinate regulatory product information (PI) documents including CCDS, SmPCs, PLs and labelling. Write and quality-control PI content, manage document change control, provide global coordination and guidance on PI processes, and ensure compliance with internal guidelines and SOPs while collaborating with Regulatory Affairs, Pharmacovigilance, Medical Affairs and commercial teams.