TI
Corporate Trade Compliance Manager managing global Jurisdiction & Classification program. Providing guidance across business stakeholders while ensuring compliance with export regulations.
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
Head of Regulatory Disclosures to lead and ensure accurate regulatory filings at Vanguard. Oversee end - to - end fund disclosures process and manage risks in a collaborative environment.
Regulatory Reporting & Compliance Specialist at American Family Insurance managing critical regulatory data calls and filings. Collaborating with diverse teams and researching state laws for compliance.
Development Airworthiness and Regulatory Engineer working with Boeing on certification activities and safety initiatives. Collaborating across teams to ensure aerospace safety standards are met in development programs.
Director of Compliance at PayPal establishing risk management strategies. Influencing executive - level decisions and partnering with stakeholders for compliance in financial technology.
Expert Compliance & Risk Consultant collaborating with Electric Engineering and Planning teams. Overseeing NERC Planning standards and compliance while developing strategies for risk mitigation.
Product Compliance Analyst ensuring regulatory compliance for a wide range of products at Grainger. Responsible for documentation, research, and internal reporting on compliance issues.
Responsible for maintaining the integrity of system access for motorist services. Reports to the Operations Services Manager in the Bureau of Motorist Services Support.
WA
Manager supporting development and implementation of compliance program at Walmart Health & Wellness. Collaborating with stakeholders to ensure regulatory compliance in pharmacy service lines with nationwide travel.
Compliance Manager ensuring effective compliance management systems and regulatory adherence in Berlin's real estate sector. Collaborating with various departments to optimize compliance measures and training initiatives.