Regulatory Affairs Assistant 350

We are seeking for a Senior Regulatory Affairs Assistant responsible for ensuring the delivery of regulatory activities performed on our regulatory affairs within the Nordic team :

• Execute on global regulatory strategy for established product(s) on continued post-approval product optimization, within relevant regions/countries and in line with the business strategy
• Lead maintenance activities on established marketing authorisations to ensure regulatory compliance and delivery according to defined milestones and timelines
• Prepare/contribute preparation of dossiers to support marketing authorization applications in close collaboration with Regulatory Strategy Lead
• Ensure review of local Product Information before submission
• Coordinate cross-product activities and strategic effort on regulatory activities as relevant
• Support preparation of health authority interactions
• Collaborate and liaise with regulatory affiliates and partners
• Develop and maintain strong collaboration and communication with main internal stakeholders of Products/projects (Regulatory Strategy Leads, Supply, Global Patient Safety, Commercial Operations and Medical Affairs)
• Actively support regulatory intelligence, regulations and guidance activities to optimise cross-functional knowledge sharing.  Proactively share knowledge and lessons learned
• Represent Regulatory in cross functional settings and cross functional working groups as relevant