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Regulatory Affairs and Compliance

  • Expertise in Strategic and Tactical Planning and Execution of life-cycle CMC development and world-wide regulatory agency interactions

  • Extensive track record in leading BLA's, CTA's, and Change Supplements

  • Knowledge and experience in Protein Biology, Biotechnology, Biologics Commercialization, and Regulatory Affairs

  • Experience in establishing strategy for moving through early to late phase production/commercialization while managing phase-appropriate change and scalability

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