Director CMC Regulatory Affairs

A company is looking for a Director of CMC Regulatory Affairs. Key Responsibilities Lead the CMC non-antibody team for cell and gene therapy technologies, ensuring global regulatory strategies are developed and executed Oversee regulatory affairs staff and contractors, establishing operational objectives and delegating tasks effectively Provide strategic input on regulatory filing documents and oversee interactions with global regulatory authorities Required Qualifications, Training, and Education Bachelor's degree in a relevant technical or scientific discipline required; advanced degree strongly preferred A minimum of 10 years of pharmaceutical/biotech industry experience, including at least 5 years in CMC Regulatory affairs related to cell and gene therapies At least 3 years of applicable managerial experience Proven track record of supporting cell and gene therapy products through development and approval Experience in dealings with FDA, EMA, or other regulatory authorities

Mar 27, 2025 - 17:12

A company is looking for a Director of CMC Regulatory Affairs. Key Responsibilities Lead the CMC non-antibody team for cell and gene therapy technologies, ensuring global regulatory strategies are developed and executed Oversee regulatory affairs staff and contractors, establishing operational objectives and delegating tasks effectively Provide strategic input on regulatory filing documents and oversee interactions with global regulatory authorities Required Qualifications, Training, and Education Bachelor's degree in a relevant technical or scientific discipline required; advanced degree strongly preferred A minimum of 10 years of pharmaceutical/biotech industry experience, including at least 5 years in CMC Regulatory affairs related to cell and gene therapies At least 3 years of applicable managerial experience Proven track record of supporting cell and gene therapy products through development and approval Experience in dealings with FDA, EMA, or other regulatory authorities