Associate Director of Regulatory Affairs

Job Summary

A company is looking for an Associate Director, Regulatory Affairs.

Key Responsibilities

• Develop and execute global regulatory strategies for assigned projects and programs
• Lead global regulatory submission processes and prepare major regulatory submissions
• Mentor Regulatory Managers and provide leadership on project teams in regulatory affairs

Required Qualifications

• BA/BS/University degree, preferably in Life/Health Sciences
• 8 years of experience in the pharmaceutical/biotechnology industry, with at least 6 years in Regulatory Affairs
• Comprehensive knowledge of applicable regulations and experience with major regulatory submissions
• Direct experience interfacing with regulatory authorities, such as the FDA
• Supervisory and mentoring experience is preferred