Senior Director, Regulatory Affairs
Fedra Molaie-Holagh is a Senior Director of Regulatory Affairs at Premier Consulting. She has 21 years of experience in the pharmaceutical and biotech industry, with 19 years focused on regulatory affairs.
In her previous role, she led the regulatory, quality, and pharmacovigilance teams at Acerus. She has also worked at Amgen, Novartis Animal Health, YM Bioscience, and BGP Pharma on teams managing innovative products at different stages of development, as well as post registration product stewardship, in a wide spectrum of therapeutic areas, including oncology, nephrology, pain, and men’s health.
Ms. Molaie-Holagh has dealt with health authorities in Canada, the US, the EU, Australia, and Japan through health authority interactions including scientific advice and EOPII meetings and and through submissions including INDs, CTAs, NDSs, NDAs, MAAs, and BLAs. She holds an HBSc in molecular genetics from University of Toronto.