As Achillion has matured into a clinical-stage biopharmaceutical company, one of the most important areas for ensuring success is Regulatory Affairs. Under the leadership of Gautam Shah, Senior Vice President and Chief Compliance Officer, an unparalleled team was assembled within the Regulatory Affairs, Quality Assurance and Pharmaceutical Technology group to ensure that Achillion is able to efficiently advance its programs through discovery, preclinical and clinical development, while meeting and exceeding the requirements from U.S. and international regulatory agencies.
Francine Cavallaro, has been a part of the Achillion team since July 2005 and is currently Senior Manager of Regulatory Affairs where she is primarily responsible for Regulatory Operations that involves implementing, maintaining and overseeing our electronic document management system, regulatory filings and archiving, and domestic and international regulatory documentation.
Throughout 2010 and 2011, Francine played a pivotal role in coordinating the successful filing of three eCTD (electronic Common Technical Document) applications for investigational new drugs to the FDA, which enabled the initiation of clinical development for ACH-1625, ACH-2684 and ACH-2928. Working tirelessly to achieve the stretch goals placed in front of her, Francine ensured that all of the necessary documentation from across the company, from preclinical study reports to manufacturing records, met all of the regulatory requirements and were published electronically in the specific manner required by the agency.
Prior to Achillion, Francine held positions of increasing responsibility in Regulatory Affairs at Alexion Pharmaceuticals and prior to that at Bayer Pharmaceuticals. Francine received her Bachelor of Science in Corporate Communications from Southern Connecticut State University.
Achillion is exceedingly proud of the dedicated, energetic and innovative employees across all disciplines.
