Will be responsible for managing all regulatory activities; developing and implementing strategies for timely approvals of Phase I-IV applications; counseling and overseeing the regulatory team; ensuring timely preparation of organized and scientifically valid FDA submissions; and interacting with regulatory agencies. Coordination of Regulatory activity with outside vendors and scientific collaborations. Will have overall responsibility for the management and implementation of regulatory submissions activities that result in market leading, high quality pharmaceutical products that meet worldwide customer requirements. Will be responsible for the development and implementation of effective processes that are consistently adhered to, and for ensuring consistent practice across all businesses. Will play a major role with the FDA and international regulatory bodies in assuring regulatory compliance with domestic and worldwide quality regulations. Will take part in the product approval regulatory submissions function. Will be responsible for providing leadership in the development of regulatory strategies for submissions of new products or modifications of products. Ensure regulatory compliance in the R&D stage of product development, which includes compliance with GLPs, ISO, or other applicable U.S. and global regulatory requirements. Will also participate in creating, upgrading and enhancing systems that allow for streamlined regulatory submissions and approval processes to reduce the cycle time in obtaining product approval from the FDA. Closely interact with manufacturing, regulatory, product submission, R&D and marketing worldwide.