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Senior Regulatory Affairs Manager Nordics
2 months ago
We are seeking a highly motivated and experienced Senior Regulatory Affairs Manager to join our team in the Nordics region. As a key member of our Regulatory Affairs team, you will be responsible for ensuring compliance with regulatory requirements in the Nordic markets, including Sweden, Norway, Finland, Denmark, and Iceland.
Your primary focus will be on post-approval/life-cycle Regulatory activities, including coordination with Nordic Regulatory Authorities and internal/external stakeholders. You will also be responsible for gathering and disseminating regulatory guidance, reviewing applications, and ensuring timely updates to regulatory information systems.
In this role, you will have the opportunity to work closely with our EU Regulatory Team, commercial teams, and external partners to ensure regulatory support for new product introductions and launches. You will also be responsible for maintaining a strong and cooperative relationship with Nordic Regulatory Authorities and external partners.
Key Responsibilities:
- Coordinate post-approval/life-cycle Regulatory activities in the Nordic markets
- Act as point of contact with Nordic Regulatory Authorities and internal/external stakeholders
- Gather and disseminate regulatory guidance
- Review applications and ensure timely updates to regulatory information systems
- Work closely with EU Regulatory Team, commercial teams, and external partners
- Maintain a strong and cooperative relationship with Nordic Regulatory Authorities and external partners
About You:
We are looking for a highly motivated and experienced individual with a strong background in Regulatory Affairs. You should have excellent communication and interpersonal skills, with the ability to build lasting relationships with external experts. You should also have a strategic mind-set, with the ability to anticipate and plan for the future.
Requirements:
- Fluent in English, both written and spoken
- Strategic mind-set, with ability to anticipate and plan for the future
- Excellent communication and interpersonal skills
- High integrity in business and people matters
What We Offer:
We offer a dynamic and challenging work environment, with opportunities for professional growth and development. You will have the chance to work with a talented team of professionals, and contribute to the success of our company.