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We are looking for a Regulatory Compliance Specialist to join our team. This role involves ensuring the quality and compliance of Investigational Medicinal Products (IMPs) by leading supplier management teams and overseeing manufacturing quality.
About the Team:
Sobi - Swedish Orphan Biovitrum AB (publ) is a global company with over 1,800 employees in more than 30 countries. We are committed to transforming the lives of people with rare and debilitating diseases through reliable access to innovative medicines.
Key Responsibilities:
- Act as the primary quality liaison for external suppliers, organizing inquiries, investigations, and audit follow-ups.
- Maintain oversight of quality topics for Sobi IMPs across markets.
- Continuously improve work processes related to quality and compliance of IMPs.
- Oversee batch record reviews and release for IMPs across US, EU, and RoW clinical trials.
