Manager, Diagnostics Regulatory Affairs | Pharmacist (m/w/d)

Job Summary

This role requires a proactive and experienced Manager of Regulatory Affairs Diagnostics to oversee and execute global regulatory strategies for BioNTech’s diagnostic and medical device products, ensuring compliance across major markets including the US (FDA) and European Union (EU IVDR). Key responsibilities involve coordinating IVD medical device co-submissions with medicinal product candidates, managing outsourced regulatory submission processes, and ensuring ongoing adherence to global regulations (e.g., FDA 21 CFR Part 820). The manager will also contribute to regulatory intelligence by monitoring the global landscape and managing regulatory assessments of product changes. Candidates must possess relevant higher education (Master's/PhD or 5+ years experience), proven experience in regulated quality environments (ISO13485), expertise in preparing regulatory documents for IVD study submissions, and fluency in English to communicate effectively with international Health Authorities. The position operates with significant independence, driving market access for BioNTech's portfolio.