Miltenyi Biotec
5001 - 10000 employees
🧬 Biotechnology
🔬 Science
Biotechnology • Science
Miltenyi Biotec is a global biotechnology company that develops and manufactures instruments, reagents, and software for cell separation, flow cytometry, single-cell analysis, and cell and gene therapy research and manufacturing. Its products and services support academic research, translational studies, and clinical manufacturing workflows, enabling isolation, analysis and manipulation of cells for immunology, neuroscience, cancer research and regenerative medicine.
Vice President, Regulatory Affairs
🔥 0 minutes ago
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Miltenyi Biotec
5001 - 10000 employees
🧬 Biotechnology
🔬 Science
Biotechnology • Science
Miltenyi Biotec is a global biotechnology company that develops and manufactures instruments, reagents, and software for cell separation, flow cytometry, single-cell analysis, and cell and gene therapy research and manufacturing. Its products and services support academic research, translational studies, and clinical manufacturing workflows, enabling isolation, analysis and manipulation of cells for immunology, neuroscience, cancer research and regenerative medicine.
📋 Description
• Lead regulatory strategy for US Biomedicine efforts • Oversee industry-specific practices and ensure compliance with regulations • Manage regulatory submissions for clinical and CMC development • Advise on CMC-related regulatory activities • Identify and communicate potential project challenges
🎯 Requirements
• B.S. or higher degree in the sciences or health-related field • 15 years of pharmaceutical/biotechnology industry regulatory experience • Extensive experience providing regulatory leadership through clinical and CMC development • Proven track record of leading NDA/BLA submissions • Demonstrated knowledge of drug development process in the US • Maintain current knowledge of industry-specific regulations
🏖️ Benefits
• Health, vision, and dental insurance • 401(k) plan
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