Fedra Molaie-Holagh, HBSc., RAC is a Vice President of Regulatory Affairs at Premier Consulting. She has 24 years of experience in the pharmaceutical and biotech industry, with 22 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 extensive experience with health authorities in Canada, the US, the EU, Australia, and Japan through health authority interactions including scientific advice and EOPII meetings and through submissions including INDs, CTAs, NDSs, NDAs, MAAs, and BLAs. She holds an HBSc in molecular genetics from University of Toronto.

To learn more about Premier Consulting’s regulatory services & support, click here.