Vice President, Regulatory Affairs - ARD
Mallinckrodt Pharmaceuticals (Specialty Brands Principal Office)
Ms. Tavakkol has held executive level positions in the biotechnology industry, as well as small and large pharma, during her 25 year career in Regulatory Affairs. A key focus of her efforts has been development of regulatory strategy, from proof of concept through successful product marketing approval, encompassing peptide and small molecule drug products across numerous therapeutic areas. Her experience includes successful Marketing Authorization Submissions in US and EU, as well as extensive knowledge of the Clinical Trial Application process in all key global regions. In her current role in the Autoimmune and Rare Disease business unit at Mallinckrodt Pharmaceuticals, she is responsible for a diverse portfolio of products that address critical unmet patient needs in the orphan drug space. Therefore, her expertise also encompasses accelerated registration pathways as well as orphan drug designation requests. Ms. Tavakkol has been a guest speaker at numerous national meetings on diverse topics in Regulatory Affairs and she places special emphasis on the important partnership between regulatory strategy and commercial objectives.
Wednesday, September 16, 2020
10:35 AM – 11:30 AM EDT