Vaccine Regulatory Specialist

13 hours ago


Stockholm, Stockholm, Sweden Scandinavian Biopharma Full time

Scandinavian Biopharma is a dynamic and innovative company dedicated to developing life-changing treatments for people worldwide. As a Regulatory Affairs professional, you will play a critical role in ensuring the quality and compliance of our vaccine products.

About the Company
  • We are a research-based specialty biopharma company with a strong focus on vaccine development and distribution.
  • We have a senior commercial team with over 20 years of experience in biotech, big pharma, and medtech industries.
  • We are well-funded, thanks to support from EU strategic research foundations, PATH, USAMMDA, and our own distribution activities.
Key Responsibilities
  • Develop and implement regulatory strategies for CMC changes, including updates to manufacturing processes and vendors.
  • Collaborate with subject matter experts to create high-quality regulatory documents, such as IMPDs and briefing documents.
  • Prioritize and coordinate submissions to regulatory authorities, including FDA, EMA, and national agencies in emerging markets.

The ideal candidate will possess strong analytical and problem-solving skills, with the ability to communicate effectively and work collaboratively within cross-functional teams.


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