Position Description:  

REGULATORY AFFAIRS: This role directs all regulatory aspects of assigned projects across project lifecycle to accomplish filing of regulatory submissions and facilitate regulatory interactions and regulatory approvals.

Serves as the principal regulatory affairs liaison to FDA and provides regulatory oversight and guidance to project teams on compliance matters, FDA requirements, clinical study issues, logistics and operational recommendations for product development. Primary responsibilities include developing regulatory submission strategies in agreement with defined product development objectives. The preparation and submission of IND and marketing applications, as well as various amendments and supplements. Interacting directly with health authorities, including FDA, to facilitate assessment of regulatory applications, including evaluating Agency questions and developing appropriate responses.