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Gretchen Bowker, M.S., RAC, is the Director of Regulatory Affairs Services and Compliance Services. In her role, she provides expertise for global regulatory affairs strategies and GXP compliance. Bowker has over 20 years of experience in life science product development in both start up and large pharmaceutical and device companies. Therefore, she appreciates the need for an adaptive regulatory strategy to meet the business requirements. Bowker has successfully negotiated approvals/activations of IND’s, CTX’s, Canadian IND’s, NDA’s, and European Market Approvals. She also has extensive experience in building and overseeing the Quality System and Programs for life science companies. Bowker frequently speaks in training courses for international organizations such as ISPE and RAPS regarding regulatory and compliance requirements. As a trained protein chemist, Bowker specializes in global Chemistry, Manufacturing and Control (CMC) regulatory requirements for biotechnology products, such as proteins, peptides and cellular based therapies. | 