Senior Director of Regulatory Affairs

Job Summary

A company is looking for a Senior Director, Regulatory Affairs.

Key Responsibilities:

• Lead global regulatory activities and manage personnel for IND/CTA preparations and maintenance
• Prepare and review regulatory documents for global product development and submissions
• Manage and mentor direct reports to achieve departmental and corporate goals

Required Qualifications:

• Bachelor's degree required; advanced degree preferred
• 12+ years of experience in pharmaceutical/biotech, with a minimum of 10 years in regulatory affairs
• Experience managing and mentoring direct reports
• Experience with regulatory activities and document submissions to regulatory bodies
• Ability to build strong relationships with diverse co-workers