Teams at Orion Pharma

Prepares and reviews pharmaceutical and quality registration dossiers, variations, amendments, annual reports, renewals, and responses to regulatory deficiencies under EU requirements. The role classifies regulatory changes, maintains regulatory records and internal systems, collaborates with stakeholders, and supports regulatory capability development. Candidates need 5–8 years of international pharmaceutical regulatory affairs experience, EU and ICH knowledge, and a Pharmacy or Chemistry degree.

Manage and coordinate high-quality product information (CCDS, SmPCs, PLs, labelling). Write and control PI documents, perform quality checks, manage document change control, and guide global PI processes in collaboration with Regulatory Affairs, Pharmacovigilance, Medical Affairs and Commercial Operations.