Director of Regulatory Affairs

Job Summary

A company is looking for a Director, Regulatory Affairs.

Key Responsibilities

• Define and execute global regulatory strategies for ophthalmology drug and combination product programs
• Provide guidance and direction regarding regulatory strategy to the department
• Lead health authority interactions and ensure high-quality submissions throughout the product lifecycle

Required Qualifications

• Bachelor's degree required; advanced degree (Masters, PhD, PharmD) preferred
• 10-15+ years in Regulatory Affairs or relevant experience in a regulated environment
• Global portfolio management and strategy experience with familiarity in ex U.S. registration requirements
• RAPS certification desired