Local Regulatory Affairs Manager Scandinavia

• Ensure timely planning, preparation, submission and follow-up of regulatory activities in Norway on all classifications tasks such as: Life cycle management of Pharma products
• Handle communication with different authorities as needed
• Reviewing AW's and, as needed, commercial material
• Lead local projects from a Regulatory Affairs perspective, connecting the dots across functions and markets
• Giving key input on how to clear a path of access to the market for various products
• Overseing local roll-out of Global NPDs/EPDs/GeoX projects
• Do Smart risk assessment - to balance both the needs of our great commercial colleagues and compliance
• Secure compliance in Veeva RIM system and GLAMS AW system (artwork)
• Ensure product information, translations, and artwork meet regulatory requirements
• Keep national databases and product monograph websites updated
• Partner closely with Global RA for alignment on globally managed products present in Scandinavia
• Take part in commercial activities in Norway

• University degree in Life Science
• Solid understanding of regulatory requirements and legal frameworks in Norway
• Minimum 5 years of experience in Pharmaceuticals is a must
• Experience with artwork maintenance and label requirements
• Strong cross-functional collaboration across Scientific Affairs, Operations, Commercial, and external stakeholders
• Solid working relationship/experience with regulatory authorities, experience with the Norwegian authorities is a plus
• Fluent in Norwegian and English
• Strong communicator, both written and verbal
• Proactive, service-minded, and solutions-oriented
• Commercially aware, with a business-driven approach to regulatory challenges
• Flexible, open-minded, and collaborative, with the ability to see the big picture and challenge the status quo
• Highly diligent, trustworthy, and skilled at prioritizing and driving tasks independently

Experience in the other classifications is appreciated but not necessary

• Opportunity to create, grow, and encourage
• Apart from a competitive salary pack, there are lots of growth opportunities to meet your personal ambitions
• Flexible schedule, hybrid model with the primary work place in the office, and life-work balance
• Responsibility for exciting and challenging projects that have a direct, visible impact on our customers and the industry
• Very positive work environment in a dynamic, international, and motivated team
• Start-up spirit while being a part of the large international organization with strong values