Senior Director, Regulatory Affairs
AnaptysBio is a clinical-stage biotechnology company developing first-in-class antibody product candidates focused on unmet medical needs in inflammation and immuno-oncology.
Nearly 25 years in industry, with nearly 20 years in Regulatory Affairs, and increasingly pivotal regulatory responsibility. Led RA & QA start-up functions, Global Regulatory Teams to form global development strategies across several aspects of Regulatory Affairs, including: CMC, Nonclinical, Clinical, and Commercial/Postmarketing. Managed global dossiers in numerous therapeutic areas, including: oncology, dermatology, cardiovascular & renal, metabolism & endocrinology, neurology, analgesia, ophthalmology, and allergy & inflammation. Experience with global health authority meetings and expertise on global health authority policies and practices. Experience with Quality Assurance, Drug Safety & Pharmacovigilance and Project Management responsibilities.
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