Scandinavian Regulatory Affairs Manager Opportunity

4 hours ago


Stockholm, Stockholm, Sweden Qrios Minds AB Full time
Company Overview:

Qrios Minds AB is a research-based specialty biopharma company committed to delivering innovative solutions that improve people's lives worldwide. Our mission is to develop groundbreaking treatments that address unmet medical needs.

Job Summary:

We are seeking a talented Regulatory Affairs Manager to join our team. In this exciting role, you will have the opportunity to apply your expertise in regulatory affairs within multiple areas, focusing on CMC aspects. You will work closely with internal and external experts to ensure the success of our regulatory strategy.

Responsibilities:

* Develop and implement regulatory strategies for our manufacturing process
* Create regulatory documents related to manufacturing, including IMPD and Briefing Documents
* 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. Minimum 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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