GRC Analyst supporting ISO27001 certification preparation at Asiera. Collaborating with technical teams for documentation and compliance.
About the role
- Local Regulatory Affairs Manager at Karo Healthcare managing Norwegian regulatory activities. Collaborating cross-functionally and ensuring compliance with regulatory requirements for pharmaceutical products.
Responsibilities
- 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
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Location requirements
Cyber GRC Senior Consultant supporting companies in enhancing cybersecurity and compliance. Collaborating with client teams to implement cybersecurity policies and conduct risk assessments.
Internal Controls & Compliance Supervisor managing compliance with SOX and internal controls at Solventum, a healthcare company enhancing solutions for healthcare professionals.
Regulatory Affairs Specialist ensuring compliance and strategic oversight at Multiverse. Drafting regulatory submissions and coordinating oversight processes within a hybrid work environment.
Director of Deposit Compliance responsible for leading compliance efforts for deposit products at Northwest Bank. Ensuring adherence to regulations and managing risk assessment processes for effective compliance operations.
Chargé de la Qualité et Conformité en alternance pour Economie d’Energie. Soutenir la conformité et le contrôle interne tout en participant à la transition énergétique en France.
Senior Specialist responsible for corrective actions in Global Trade Compliance at L3Harris. Track compliance incidents and facilitate corrective action processes across US and non - US jurisdictions.
Regulatory Affair Specialist at Capgemini Engineering ensuring regulatory compliance with medical device documentation. Supporting regulatory activities and monitoring the regulatory context impact on site processes.
Compliance Analyst role at Leve Saúde ensuring adherence to regulations in the health sector. Responsibilities include audits, policy management, and due diligence processes.
Governance, Risk & Compliance Specialist at Quilter providing oversight on governance, risk, and compliance activities, strengthening Quilter Invest’s risk management culture across the organization.