Deputy Director of Global Regulatory Strategies—New Jersey

Deputy Director of Global Regulatory Strategies—New Jersey Tanner and Associates is recruiting a Deputy Director of Global Regulatory Strategies based out of New Jersey. Responsibilities: Planning and managing regulatory activities for regulatory projects within an assigned product area. Managing regulatory submissions for U.S. and foreign regulatory bodies in support of product development programs Developing and implementing regulatory plans throughout the product development lifecycle Collaborating with Global project teams to ensure that all regulatory requirements are properly resourced and communicated Working closely with other regulatory groups, clinical research, product development teams, and commercial groups Leading interactions with regulatory authorities and regulatory filings, ie. FDA, EU Agencies including the EMEA Managing submissions and maintenance of licenses based on product and regulatory strategies Providing regulatory advice regarding issues/strategies surrounding new product development and ongoing product support Requirements MS, PhD, PharmD or MD 10 or more years of pharmaceutical industry experience At least 5 years experience with a proven record in regulatory affairs In depth knowledge of clinical trial methodology, clinical auditing and drug safety data analysis Extensive knowledge of FDA/EMEA requirements including ICH guidelines and regional requirements Sound understanding of current global and regional trends in regulatory affairs as it may impact the company’s business Must demonstrate strategic ability and strong leadership skills and management skills of global regulatory teams operating in a matrix environment and the coordination of global regulatory managers Experience from investigational to marketing registration in major regions of the world is preferred #J-18808-Ljbffr TANNER & ASSOC INC