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Regulatory Affairs Manager Nordic Region
10 hours ago
We are seeking a highly motivated and detail-oriented Regulatory Affairs Manager to join our team in the Nordic Region. As part of our EU Regulatory Affairs team, you will be responsible for post-approval/life-cycle regulatory activities in the Nordic markets (Sweden, Norway, Finland, Denmark, Iceland) for our company's Nordic portfolio.
Main Responsibilities:
- Act as point of contact with Nordic Regulatory Authorities and internal/external stakeholders for our Nordic Office (Regulatory partners, translators, Quality, Supply Chain, Medical/PV, Commercial) for our Nordic portfolio.
- Keep an oversight of Lifecycle maintenance activities and provide strategic advice to our cross-functional team on regulatory matters; ensure alignment on strategies proposed/discussed with the rest of the EU Regulatory Team.
- Support our Nordic teams cross-functionally to ensure regulatory support when needed.
About You
We are looking for highly motivated individuals who are passionate about making a meaningful difference to patients' lives. For this role, you will have:
- A strategic mindset, with ability to anticipate and plan for the future and see a broader picture; attention to detail; high quality, critical thinking, process and performance orientated.
- A positive and 'can-do' approach; biased towards finding solutions and win/wins; energizes, inspires, and empowers staff.
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