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Kristin Murray

SVP, Head of Regulatory Consulting Services

Kristin is an executive level regulatory and quality leader with a successful track record of aligning strategic regulatory strategies and quality requirements with business objectives. Strategic, results-oriented, creative, and resourceful leader with more than 30 years of extensive experience in the pharmaceutical industry focused on Regulatory strategy including clinical, nonclinical, analytical, technical and facilities operations. Collaborative and forward-thinking with intellectual creativity and demonstrated success in development of innovative and risk-based global regulatory strategies. Kristin has numerous successful negotiations with global regulators on complex regulatory issues to meet business goals. She has strong technical and strategic regulatory expertise across a broad spectrum of biologic, drug, vaccine, plasma, gene therapy and combination products and various therapeutic areas. Kristin is experienced with Rare, Neurodegenerative, Immunology / anti-inflammatory, Muscular Skeletal, Oncology and Hematology indications. Kristin is an experienced Quality leader, including Quality Systems development and oversight, CMO oversight and Risk Management. Additionally she is an energetic people leader recognized for bringing global and culturally diverse team members together to form a cohesive and resilient team.

Prior to Syner-G Kristin’s experience includes Pfizer, Shire, Ultragenix, and Xalud Therapeutics where she held roles of increasing responsibility.

Kristin has contributed to >30 INDs/CTAs and marketing applications across multiple therapeutic areas, product types and global regions. Highlights include strategic roles in global approvals for Prevnar 13®, Takhzyro®, and the Mylotarg® resubmission.

Kristin has demonstrated lifecycle management of numerous commercial products including Cynryze® (lifting of Warning Letter), Gammaguard® and Flexbumin® (greenfield manufacturing site), Neumega® (including sunsetting of product), Natpara®, and Gattex®. (including global registrations).

Education

  • MA in Biochemistry, Harvard University (Extension School), Cambridge, MA
  • BS Biochemistry, Bates College, Lewiston, ME

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