Biopharma Compliance Manager

13 hours ago


Stockholm, Stockholm, Sweden Scandinavian Biopharma Full time

We are looking for an experienced Regulatory Affairs professional to join our team at Scandinavian Biopharma. As a key member of our team, you will be responsible for ensuring the regulatory compliance of our vaccine products.

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.
Requirements
  • Minimum MSc or equivalent degree in a relevant field, plus 5+ years' experience in Regulatory Affairs.
  • Proven expertise in biological pharmaceutical products, including vaccines and immunoglobulins.
  • Excellent communication and project management skills, with ability to work independently and collaboratively.

The successful candidate will possess strong analytical and problem-solving skills, with the ability to prioritize tasks effectively and meet deadlines.


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