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Regulatory Affairs Director

2 months ago


Stockholm, Stockholm, Sweden MSI Pharma Full time
Senior Manager of Regulatory Affairs

MSI Pharma is seeking a seasoned professional to lead our Regulatory Affairs team in the Nordics. As a Senior Manager, you will be responsible for guiding product development teams to ensure compliance with local regulations, assessing and submitting regulatory documentation, and monitoring product claims.

Key Responsibilities:

  1. Develop and implement regulatory strategies to ensure compliance with Swedish regulations and provide an overview of Denmark, Finland, and Norway.
  2. Lead a team of 7 Regulatory professionals across the Nordics, representing the RA function.
  3. Collaborate with product development teams to ensure regulatory requirements are met.
  4. Stay up-to-date on regulatory changes and ensure compliance with quality standards.
  5. Approve promotional materials and product artwork.
  6. Manage audits and inspections.
  7. Drive process improvements.

Requirements:

  1. Bachelor's degree or higher in a relevant field.
  2. 8+ years of experience in Regulatory Affairs, with expertise in Medicinal products, Cosmetics, and/or Medical Devices.
  3. Proven leadership and coaching skills.
  4. Proficiency in English.

Why MSI Pharma?

As a world-leading Consumer Health company, we offer a dynamic and challenging environment where you can shape the future of healthcare with innovative regulatory strategies. If you're a visionary leader passionate about Regulatory Affairs and committed to excellence, this role is perfect for you.