Job summary
This fixed-term position supports regulatory activities across the Nordic countries within the pharmaceutical sector. The role focuses on coordinating regulatory submissions, managing artwork and labelling for products, and ensuring compliance with evolving regulations to enable timely market access. The position requires close collaboration with internal teams and regional health authorities to maintain supply and regulatory adherence for assigned products.
Location and work setup
- Location
- Oslo
- Work setup
- Hybrid
Responsibilities
Lead management of artwork and labelling projects to ensure accuracy and compliance; prepare and compile regulatory submissions to secure approvals; monitor and interpret changes in labelling regulations and integrate these into company processes; maintain communication with national health authorities to address regulatory questions; collaborate cross-functionally to align on plans and ensure uninterrupted patient access; maintain documentation and regulatory records following current standards; update and enforce SOPs; contribute to continuous improvement initiatives and share best practices within the team.
Qualifications
University degree in Pharmacy or equivalent; relevant experience in pharmaceutical regulatory affairs; solid knowledge of regulatory submission formats and product lifecycle management; understanding of applicable legislation and procedures; proven ability to work with regulatory authorities; excellent command of English and at least one Nordic language; strong interpersonal and project management skills with ability to influence stakeholders and manage projects to completion.