Sr. Director, Reg Affairs

Role Summary

As the Senior Director, Regulatory Affairs, you are a driven global regulatory leader with expertise in regulatory strategy development and execution. You excel in navigating global health authority interactions, leading cross-functional teams, and driving clinical and licensing submissions. This role reports to the QED Head of Regulatory Affairs and provides leadership in regulatory activities for assigned programs, including developing global regulatory strategies, leading submissions, and managing critical health authority interactions as well as leading regulatory staff. This is a hybrid role based in the San Francisco/Palo Alto area.

Responsibilities

• Provide leadership in creating and executing proactive regulatory strategies for product development, approval, and registration
• Apply knowledge of global quality/regulatory standards and guidelines to ensure requirements are met across programs
• Partner with internal s...