Deputy Director of Global Regulatory Strategies

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.

• 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

• MS, PhD, Pharm
  
  D 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