Regulatory Affairs Director for Swedish Biopharmaceuticals

2 days ago


Stockholm, Stockholm, Sweden Qrios Minds AB Full time
Job Description:

We are seeking a skilled Regulatory Affairs Manager to join our dynamic team at Qrios Minds AB. As a key member of our organization, you will play a crucial role in ensuring the regulatory compliance of our biopharmaceutical products.

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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