Senior Regulatory Policy Director

Job Summary

A company is looking for a Sr. Regulatory Policy Director who will lead the Regulatory Policy function and engage with external stakeholders.

Key Responsibilities

• Lead the Regulatory Policy function, focusing on US regulations and guidance impacting prescription drug development
• Represent Regulatory Affairs at meetings with FDA and other government agencies, and strengthen organizational awareness of regulatory priorities
• Develop regulatory policy analyses and manage advocacy efforts, ensuring effective communication of regulatory impacts to stakeholders

Required Qualifications

• BS/BA degree in Regulatory Sciences, Business, Political Science, or related field with 12+ years of relevant experience, or a Master's Degree with 10+ years of experience
• In-depth understanding of regulatory and industry issues with the ability to develop strategic recommendations
• Established external presence in regulatory policy and expertise working with US regulators
• Proven ability to build effective relationships with internal and external stakeholders
• Experience leading cross-functional initiatives and mentoring team members