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Pharmaceutical Regulatory Expert Senior Position
11 hours ago
We are seeking an accomplished Regulatory Affairs Expert to lead our post-approval/life-cycle regulatory activities in the Nordic markets (Sweden, Norway, Finland, Denmark, Iceland). As part of our EU Regulatory Affairs team, you will be responsible for managing regulatory submissions, maintaining compliance with regulations, and ensuring alignment on strategies proposed/discussed with the rest of the EU Regulatory Team.
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.
- Review and approval of artworks initiated by the EU Regulatory Team specifically for the Nordic markets.
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 deep understanding of regulatory affairs processes and procedures.
- An excellent track record of building relationships with regulatory authorities and external partners.
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