Melina Cioffi

Melina Cioffi has a diverse work experience in the field of regulatory affairs. Melina currently holds the position of VP of Regulatory Affairs at Aquestive Therapeutics since August 2020. Prior to that, they were the Head of Regulatory Affairs at Axsome Therapeutics from March 2020 to August 2020.

From 2010 to 2018, Melina worked at Forest Laboratories (now Allergan) in various roles, including Director, Associate Director, and Assistant Director of Regulatory Affairs.

Before that, they served as the Regulatory Affairs Senior Manager at Dainippon Sumitomo Pharma from May 2008 to May 2010. Melina'sresponsibilities included leading regulatory activities for clinical components and operational activities of NDA for schizophrenia, as well as participating in IND submissions and global clinical trial start up activities for bipolar depression and overactive bladder.

Melina started their career as a Post-Doctoral Fellow at Novartis from July 2006 to May 2008. Melina also gained experience through an externship at the FDA from November 2005 to January 2006, where they were exposed to the internal hierarchy and processes within the agency.

In 2003, Melina had an internship at McNeil Consumer & Specialty Pharmaceuticals, where they gained hands-on experience in drug regulatory affairs and worked on promotional review for various compounds and OTC products.

Overall, Melina Cioffi has a strong background in regulatory affairs and has held key positions in multiple pharmaceutical companies, contributing to various regulatory activities throughout their career.

Melina Cioffi earned a Doctorate degree in Pharmacy from the University of the Sciences in Philadelphia, where they attended from 2000 to 2006.