The position, located at the Otsuka Maryland Research Institute (OMRI) in Rockville, Maryland, reports to the Senior Vice President, Regulatory Affairs. Your basic role is to provide regulatory expertise and support for pre-clinical and clinical areas for Otsuka's investigational and marketed products. Your primary duties are:

1.) Act as primary liaison between Otsuka and FDA for assigned investigational and marketed products, interacting with FDA personnel up to and including the Division Director level.

2.) Provides guidance to Project Teams on steps necessary to comply with newly enacted regulations and guidelines.

3.) Determines regulatory requirements for clinical and pre-clinical submissions to FDA for assigned investigational products.

4.) Reviews documents intended for submission to FDA to assure compliance with regulatory standards.

5.) For assigned products, assures that Regulatory Affairs is adequately represented on project teams.

Candidate Requirements:

1.)We seek a regulatory professional with a minimum of 10 years of pharmaceutical industry regulatory experience.

2.)We seek a professional with an advanced degree - PhD, MD, DVM or equivalent.

3.)You must have a proven track record of supporting drug development including knowledge of drug laws, regulations and guidelines. Experience negotiating with CDER on investigational and marketed drugs is highly desirable.

4.)For the best fit, you must have excellent oral and written communications skills including the ability to discuss scientific / technical data and regulatory requirements with colleagues and the FDA.

Compensation:

A compensation package will be designed to attract outstanding talent and will include a base salary, performance bonus and excellent benefits.