Regulatory Strategy Manager in Scandinavian Biotech

3 days ago


Stockholm, Stockholm, Sweden Qrios Minds AB Full time
Job Title: Regulatory Affairs Manager

We are seeking a highly motivated and experienced Regulatory Affairs Manager to join our team at Qrios Minds AB. In this role, you will play a critical part in developing and implementing our regulatory strategy, ensuring the compliance of our biopharmaceutical products with regulatory requirements.

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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