Anila Mico

Anila Mico has extensive experience in regulatory affairs, with a focus on pharmaceutical products. Anila began their career in 2000 as a Regulatory Affairs Specialist at CODAL-SYNTO LTD. where they prepared drug applications for marketing licenses. Anila then worked at VistaPharm, Inc. as a Chemist, performing drug chemical analysis and analytical method development. Anila later joined Belcher Pharmaceuticals, Inc. as a Regulatory Affairs Specialist, responsible for preparing ANDA submissions and product labels.

In 2006, Anila joined Fresenius Medical Care North America as a Senior Regulatory Affairs Specialist, where they prepared NDA, IND, and ANDA submissions, represented regulatory affairs in project teams, and participated in FDA meetings. Anila then worked at EMD Serono as an Associate Director, Global Regulatory Fertility & Endocrinology, before joining the Regulatory Affairs Professionals Society (RAPS) as an RAC.

Anila's career continued to progress, and they held positions at Pharmalucence, Inc. as a Director and Senior Director of Regulatory Affairs, and at Tetraphase Pharmaceuticals as a Senior Director and Executive Director of Regulatory Affairs. At both companies, they were responsible for regulatory strategy and submissions for various regulatory authorities.

Most recently, Anila served as Vice President and later Senior Vice President of Regulatory Affairs at GENFIT. Anila'srole involved providing regulatory strategy for products in orphan indications, leading health authority meetings and communications, and serving as the point of contact for the FDA/US Agent for GENFIT.

Throughout their career, Anila has consistently demonstrated their expertise in regulatory affairs, strategy development, and communication with health authorities.

Anila Mico holds a Master of Science degree in Natural Products from the Mediterranean Agronomic Institute of Chania, Greece, which they obtained from 1995 to 1997. Prior to that, they completed their undergraduate studies in Industrial Chemistry at the University of Tirana, Albania, from 1986 to 1991. Anila Mico possesses additional certification in RAC, although the institution and specific year of obtaining this certification are not provided.