Local Regulatory Affairs Manager
Karo Healthcare
full-time
Posted on:
Location Type: Hybrid
Location: Oslo • 🇳🇴 Norway
Visit company websiteJob Level
Mid-LevelSenior
About the role
- Take ownership of the active Norwegian regulatory portfolio for known products such as IBUX, Paracet and Asana.
- Shape processes and strategies that directly influence product access and availability
- Collaborate cross-functionally with local market teams and global functions
- Grow your career within a dynamic, ambitious company
- 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. Here you’ll directly be a key stakeholder in our growing business by:
- Give key input on how to clear a path of access to the market for various products
- Oversee local roll-out of Global NPDs/EPDs/GeoX projects
- 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
Requirements
- 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 in the other classifications is appreciated but not necessary. We, as a local team, will ensure you are onboarded and trained in non-pharma classifications and will support throughout.
- 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
Benefits
- 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
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
regulatory requirementslife cycle managementartwork maintenancelabel requirementsregulatory activitiesrisk assessmentproduct information managementtranslationscomplianceVeeva RIM
Soft skills
cross-functional collaborationcommunicationstakeholder managementstrategic thinkingproblem-solvingownershipadaptabilityteamworkleadershipinterpersonal skills
Certifications
university degree in Life Science