The Regulatory Affairs Associate will have responsibility for the implementation of regulatory strategies for nano-scale emulsions as topical and/or mucosal products for the treatment and prevention of infectious diseases.  This person will collaborate with academic, industry and Nanobio colleagues to insure that regulatory submissions are complete, timely and in compliance with FDA standards.

Key responsibilities include:

• Interaction with contract research organizations (CRO’s) on clinical protocols, consent forms, and investigator documents to monitor compliance with GCP and FDA regulations.

• Interaction with other clinical and regulatory colleagues and consultants to insure collection, management and submission of appropriate documents for regulatory submissions.

• Preparation of IND, ISS, ISE and safety updates for submission to FDA and international regulatory authorities.

• Create and maintain database for tracking project documentation/submissions and communication between all essential parties involved in project(s).

Requirements:

• BA or MS in biological, pharmaceutical or related area.

• At least 5 years of experience in pharmaceutical/biotechnology, regulatory or related field, experience with either CDER or CBER preferred.

• Independent, self motivated and able to multi-task with proficiency in WORD, EXCEL and PowerPoint.

• Enjoys working in an entrepreneurial, start up environment with the flexibility and initiative to move projects forward in a small, but growing biotechnology company.