Jessica is a senior regulatory professional with 10 years of experience in the global biopharmaceutical industry. She provides strategic product development and approval strategies to pharmaceutical and biotechnology companies with a focus on investigational therapies for the treatment of rare, serious and life-threatening conditions.
In addition to leading and managing the design and implementation of innovative product development strategies, Jessica also directs the preparation of worldwide regulatory submissions: New Drug Applications (NDAs)/Biologic License Applications (BLAs), Clinical Trial Applications (CTAs)/Investigational New Drug Applications (INDs), Orphan Drug Designations (ODDs), Breakthrough Therapy Designations (BTDs), Fast Track Designations (FTDs), pediatric development plans and briefing packages. Her projects include interactions with regulatory agencies (pre-IND, end of phase 2, and pre-NDA meetings, scientific advice etc.) as well as direct interactions with clients.
Jessica serves as a Regulatory Representative for Health Canada and is an FDA expert liaison/US Authorized Agent for CBER and CDER regulated drugs and biologics. She has direct FDA meeting, interactions, and successful negotiation experience with the Divisions of Neurology, Psychiatry, Anesthesiology, Oncology, Hematology, Gastroenterology, Pulmonary, Ophthalmology, and the Office of Cellular, Tissue, and Gene Therapies.
Prior to joining NovusLife, Jessica led and coordinated global regulatory activities at Voisin Consulting Life Sciences, and Millennium/Takeda Pharmaceuticals. She also managed clinical trial submissions for PAREXEL International, and Dana Farber Cancer Institute.
Jessica is an active Committee Member for the Drug Information Association (DIA)’s Rare Disease and Orphan Products Programs. She holds a Bachelors degree in Psychology and an advanced degree and certification in Regulatory Affairs for the life sciences industry.