Regulatory Affairs Director

2 days ago


Stockholm, Stockholm, Sweden PharmaRelations ApS Full time
Job Description

We are seeking an experienced Senior Director Regulatory Affairs to lead our regulatory strategies and drive compliance across the Nordics.

Main Responsibilities:
  • Develop and implement tailored regulatory strategies for OTC products in the Nordic region.
  • Ensure submission packages meet Nordic regulatory standards, eliminating deficiencies prior to submission.
  • Monitor and influence assessment processes to expedite approvals and optimize outcomes, including product labeling and supply continuity.
  • Communicate regulatory changes to the global team and address critical issues such as batch recalls or release challenges.
  • Submit and maintain local medicinal product information, including Patient Information Leaflets, SmPCs, packaging texts, RMPs, and Educational Material as needed.

Key Skills:

  • Broad regulatory experience in medicinal products, preferably in OTC products and commercial aspects within the pharmaceutical industry.
  • Strong negotiation and regulatory compliance skills, as well as proven leadership experience with a business-minded and detail-oriented approach.
  • Proficiency in a local Nordic language and English is essential.


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