CMC Regulatory Specialist

7 hours ago


Stockholm, Stockholm, Sweden Scandinavian Biopharma Full time

Are you looking for a challenging and rewarding career in Regulatory Affairs? Do you want to make a real impact on people's lives by contributing to the development of innovative healthcare solutions? If so, we invite you to apply for the position of CMC Regulatory Specialist at Scandinavian Biopharma.

As a CMC Regulatory Specialist, you will play a critical role in ensuring that our products meet the highest standards of quality, safety, and efficacy. You will work closely with our regulatory team to develop and implement regulatory strategies for the development and implementation of changes in the manufacturing process.

In this role, you will be responsible for coordinating and compiling regulatory submissions for FDA, EMA, and national authorities. You will also work closely with subject matter experts to develop regulatory documents related to manufacturing, such as IMPD, Module 3, and Briefing Documents.

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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