RA Director

Under the direction of the VP of Regulatory Affairs, the Director of Regulatory Strategy will direct and manage Regulatory Affairs activities for developing product life cycles. You should be confident leading interactions with the FDA and Health Authorities. You will provide regulatory support, guidance, and expertise to internal groups such as well as industry partners. If you are excited to take the lead in regulatory strategic development for a small/midsized company in the Greater Boston Area, then be certain to send your details over. This is an extremely exciting opportunity offering a competitive salary $140,000-$180,000 as well as generous benefits including bonus and stock. The right candidate should be seasoned on the development programs and be able to assure that regulatory documents are in compliance with health authority regulations and interacting with US and international health authorities. Requirements: -Minimum of BS degree in life sciences or related field, ideally an MS or advanced degrees strongly preferred - You should have et least 12 years of experience in the pharmaceutical industry including 8+ years regulatory affairs -You should have already excelled at the Associate Director, and preferably the Director level -Experience reviewing outgoing FDA correspondences -Knowledge of domestic and international regulations and guidelines -Understanding of drug development process - Understanding of FDA regulatory requirements; EU,Canada, and ROW experience desirable -Strong strategic and analytical abilities -Ability to mentor staff Initial phone screenings are filling up fast!

To find out more about Real, please visit www.realstaffing.com