James Mcallister

Some informations about James Mcallister:
Senior Director, Regulatory Affairs at Anaptysbio
San Diego.
San Diego State University-California State University
Twenty years in industry, with 15 in Regulatory Affairs, and increasingly pivotal regulatory responsibility. Led numerous 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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