Profile

Virginia Anastassova, RAC

Starfish Medical

Contact Details

Starfish Medical
4951 Del Monte Ave
Bronze Member
RegEx Pro

Bio

Regulatory Affairs professional with more than 17 years experience in the pharmaceutical and medical device (class III/IV) industry. Extensive scientific background with excellent knowledge of US (FDA), European, Canadian (Health Canada), Japanese (PMDA), and Australian (TGA) drug and device regulations, RAC (US). Skills include experience in preparation of Regulatory strategy, NDA, MAA, IND, IDE, PMA, 510(K), and CTA submissions and supplements, and successful submission and approval plus GXP experienced, including GCP, GLP and GMP. Analytical, manages critical detail and works well managing an interdisciplinary/multicultural team while focusing on the goal.

Position Title

Manager

Job History

StarFish Medical
Regulatory Affairs Manager, Senior QA Specialist
June 2015 - present

Regional Interests

Canada, Europe, United States

Product Interests

Innovative Pharmaceuticals