Regulatory Affairs Manager Position

4 days ago


Stockholm, Stockholm, Sweden Scandinavian Biopharma Full time

At Scandinavian Biopharma, we are committed to improving people's lives worldwide by developing innovative vaccines and biopharmaceuticals. As a Regulatory Affairs Manager, you will play a crucial role in ensuring the regulatory strategy for our products is aligned with global regulatory requirements.

Main Responsibilities
  • Develop and implement the regulatory strategy for the development and implementation of changes in the manufacturing process, including changes in the manufacturer (drug substance and drug product)
  • Collaborate with subject matter experts to develop regulatory documents related to manufacturing (e.g. IMPD, Module 3, Briefing Document)
  • Compile and submit regulatory documents to FDA, EMA, and national authorities in third-world countries (IND, CTA, RtQ etc.)
Key Qualifications
  • Minimum MSc or equivalent degree with + 5 years' experience in Regulatory Affairs
  • Experience working on projects in development
  • Experience working with biological pharmaceutical products (biologics)
  • Excellent communication skills in speech and writing (English and Swedish)
  • Experience working with vaccines and/or WHO prequalification is a plus


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