
Regulatory Affairs Specialist in Biopharmaceuticals
8 hours ago
Qrios Minds AB is seeking a highly experienced Regulatory Affairs Manager to join our team. As a regulatory CMC expert, you will play a crucial role in coordinating the regulatory strategy for the development and implementation of changes in the manufacturing process.
- Develop and implement regulatory strategies 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 the manufacturing, such as IMPD, Module 3, and Briefing Document.
- Coordinate and compile regulatory submissions for FDA, EMA, and national authorities in third world countries.
Key Requirements:
- Minimum MSc or equivalent degree with + 5 years' experience in Regulatory Affairs.
- Proven track record of working on projects in development.
- Experience working with biological pharmaceutical products (biologics).
- Excellent communication skills in speech and writing (English and Swedish).
- Bonus points for experience working with vaccines and/or WHO prequalification.
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