Associate Director, Regulatory Affairs

The Associate Director, Regulatory Affairs will be responsible for developing and delivering innovative, breakthrough global regulatory strategies for product development and approval, in alignment with the global business strategy. Responsible for leading a comprehensive and strategic approach to developing and executing integrated global regulatory strategies that account for the complex interplay between major Health Authorities (including US, EU, JP, and China). Represent the company with domestic and international regulatory authorities, contractors and corporate partners. Provide regulatory support for various departments, projects, and teams/committees. May manage direct reports.

• Responsible for developing and executing global regulatory strategies for assigned projects and programs.
• Support development of the preclinical and clinical development plan.
• Identify and assess regulatory risks associated wit...