Regulatory Affairs Expert

7 hours ago


Stockholm, Stockholm, Sweden Scandinavian Biopharma Full time

Scandinavian Biopharma is a research-based specialty biopharma company dedicated to improving people's lives by developing innovative solutions for various health conditions. We are currently seeking an experienced Regulatory Affairs Expert to join our dynamic team.

The ideal candidate will have a strong background in regulatory affairs, with a focus on CMC (Chemistry, Manufacturing, and Controls) regulations. They will be responsible for coordinating the regulatory strategy for the development and implementation of changes in the manufacturing process, including changes in the manufacturer.

As a key member of our team, the successful candidate will work closely with subject matter experts to develop regulatory documents related to manufacturing, such as IMPD, Module 3, and Briefing Documents. They will also coordinate and compile regulatory submissions for FDA, EMA, and national authorities in third-world countries.

To succeed in this role, you will need excellent communication skills, both written and verbal, as well as experience working with biological pharmaceutical products and vaccines. A strong attention to detail and problem-solving skills are essential for ensuring accuracy and efficiency in your work.

At Scandinavian Biopharma, we value a collaborative and entrepreneurial environment where everyone supports each other to achieve common goals. If you are passionate about making a difference in people's lives and have a strong interest in regulatory affairs, we encourage you to apply for this exciting opportunity.

Key Responsibilities:
  • Develop and implement regulatory strategies for the development and implementation of changes in the manufacturing process
  • Coordinate and compile regulatory submissions for FDA, EMA, and national authorities
  • Work closely with subject matter experts to develop regulatory documents related to manufacturing
  • Collaborate with cross-functional teams to ensure regulatory compliance


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