![Qrios Minds AB](https://media.trabajo.org/img/noimg.jpg)
CMC Expert for Global Biopharma Company
2 days ago
As a Regulatory Affairs Manager at Qrios Minds AB, you will play a vital role in shaping the regulatory strategy for our biopharmaceutical products. Your primary responsibility will be to ensure the compliance of our products with regulatory requirements, while also driving business growth through strategic partnerships and collaborations.
Key Responsibilities:
1. Develop and implement regulatory strategies for our manufacturing process, including changes to drug substance and drug product.
2. Collaborate with subject matter experts to create regulatory documents related to manufacturing, such as IMPD and Briefing Documents.
3. Coordinate and compile regulatory submissions for FDA, EMA, and national authorities in third-world countries.
Requirements:
To be successful in this role, you will need:
1. A minimum of 5 years' experience in Regulatory Affairs, preferably with an MSc or equivalent degree.
2. Proven experience working on projects in development, particularly with biological pharmaceutical products (biologics).
3. Excellent communication skills in English and Swedish, both written and spoken.
4. Experience working with vaccines and/or WHO prequalification is a plus
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