Hazar A. Granko, RPh PhD
Associate Director, Regulatory Affairs
Hazar A. Granko, RPh, PhD is Associate Director, Regulatory Affairs at IMPACT. Dr. Granko has over 9 years of experience in medical writing, clinical research, regulatory affairs, and drug development strategy. Prior to joining IMPACT, Dr. Granko served as Associate Director, Regulatory Affairs at Pearl Therapeutics and previously as Senior Group Manager, Regulatory Affairs and Strategic Drug Development Services at SRA International (formerly Constella Group/Lineberry Research Associates).
Dr. Granko has managed project teams on a number of complex regulatory writing and consulting projects, including regulatory submissions (INDs, NDAs/BLAs), scientific document preparation, and strategic drug development. Specifically, Dr. Granko has been involved in managing and/or authoring clinical sections of 9 NDA/BLA submissions (including ISSs, ISEs, CSSs, CSEs, Clinical Overviews), 6 of which were in CTD format. She also has extensive experience in the preparation of INDs (including in eCTD format), CSRs, protocols, Investigator Brochures, briefing documents, narratives, and manuscripts. Dr. Granko has also conducted feasibility assessments and clinical gap analyses, provided clinical content review of promotional materials, developed publication strategies, and prepared clinical development plans. Her work has encompassed a broad range of therapeutic areas including respiratory, rheumatology, CNS, women’s health, cardiovascular, infectious disease, and oncology.
Dr. Granko holds a BS in Pharmacy from Long Island University’s Arnold and Marie Schwartz College of Pharmacy and Health Sciences and a PhD in Pharmacology from Emory University School of Medicine.