Regulatory Compliance Specialist

9 hours ago


Stockholm, Stockholm, Sweden PharmaRelations ApS Full time

Overview of PharmaRelations ApS

Our client is one of the leading Sales, Marketing and Distribution companies in Sweden. Their vision is to make brands more successful.

Job Summary

We are seeking an experienced Senior Director Regulatory Affairs to establish and lead regulatory strategies, particularly for OTC products, as we build our pharmaceutical portfolio.

Main Responsibilities:

  • Take ownership of regulatory activities across a range of areas, including MAs (MRP/DCP and national licenses).
  • 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.

Requirements

  • Education: Life Science Degree or equivalent, with broad regulatory experience in medicinal products. Experience in food supplements, cosmetics, and medical devices is advantageous.
  • Experience: Minimum of 10 years in regulatory activities, with a focus on OTC products and commercial aspects within the pharmaceutical industry.


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