Director of Regulatory Affairs

Job Summary

A company is looking for a Director, Regulatory Reporting & Submissions.

Key Responsibilities

• Lead product-related regulatory compliance, submissions, and reporting for all regulated operating companies
• Ensure all regulatory reporting obligations are met
• Monitor and evaluate the impact of new or evolving regulatory requirements

Required Qualifications

• Bachelor's degree; regulatory certification is a plus
• 10+ years of experience with FDA regulations
• Prior experience developing and implementing regulations and guidance documents
• Experience working at FDA or the Center for Tobacco Products is a plus
• Project and people management experience