Regulatory Affairs Lead

10 hours ago


Stockholm, Stockholm, Sweden Scandinavian Biopharma Full time

At Scandinavian Biopharma, we are committed to delivering life-changing treatments to people worldwide. As a key member of our team, you will play a pivotal role in ensuring the regulatory compliance of our products, particularly vaccines and biologics.

Main 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.
Key Qualifications
  • Minimum MSc or equivalent degree in a relevant field, plus 5+ years' experience in Regulatory Affairs.
  • Proven track record of working on development projects, particularly in the biopharmaceutical sector.
  • Expertise in biological pharmaceutical products and WHO prequalification is highly valued.

The ideal candidate possesses excellent communication skills, both written and verbal, with fluency in English and Swedish. Strong organizational and problem-solving abilities are essential for success in this role.



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