Regulatory Affairs Manager Nordic Region

10 hours ago


Stockholm, Stockholm, Sweden Bondi Chefrekrytering AB Full time

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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