Biologics CMC Regulatory Lead
hirelifescienceNorth Wales (PA)
About the role
Hire Life Science seeks an Associate Principal Scientist, Regulatory CMC - Biologics (R4) to lead global regulatory strategies for our biologics portfolio. You will author CMC sections, coordinate IND/BLA submissions, and mentor scientists on regulatory science and compliant documentation.
You will collaborate across manufacturing, analytical, quality, and clinical teams, directing pre- and post-approval activities while ensuring timely submissions and alignment with global regulatory
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