Nordic Regulatory Compliance Expert

1 day ago


Stockholm, Stockholm, Sweden PharmaRelations ApS Full time

The Role

PharmaRelations ApS seeks a seasoned Sr Director to drive impactful change in regulatory affairs. You will shape regulatory strategies for OTC products as we expand into the pharmaceutical industry.

Main Accountabilities:

You will take ownership of regulatory activities across a range of areas, including MAs (MRP/DCP and national licenses), and oversee the marketing of cosmetics, medical devices, and food supplements across the Nordics.

  1. Collaborate with the MAH's global team and local colleagues to develop and implement regulatory strategies tailored to the Nordic region.
  2. Critically evaluate submission packages to meet Nordic regulatory standards, eliminating deficiencies prior to submission.
  3. Monitor and influence the assessment process to expedite approvals and optimize outcomes, including product labeling and supply continuity.
  4. Ensure compliance by communicating any regulatory changes to the global team and addressing critical issues such as batch recalls or release challenges.


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