
Nordic Regulatory Compliance Expert
1 day ago
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.
- Collaborate with the MAH's global team and local colleagues to develop and implement regulatory strategies tailored to the Nordic region.
- Critically evaluate submission packages to meet Nordic regulatory standards, eliminating deficiencies prior to submission.
- Monitor and influence the assessment process to expedite approvals and optimize outcomes, including product labeling and supply continuity.
- 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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