Global Regulatory Lead

Job Summary

A company is looking for a Global Regulatory Lead Partner.

Key Responsibilities

• Ensure maintenance of global registrations for assigned products, including US and EU markets
• Lead and execute regulatory activities supporting life cycle management, including submission strategy development and risk identification
• Manage regulatory agency communications and submissions, including responses to agency questions and labeling negotiations

Qualifications and Requirements

• Bachelor's degree or higher in a relevant field such as pharmaceuticals, chemistry, or regulatory affairs
• 5+ years of experience in regulatory affairs and/or regulatory framework of major health authorities
• Experience working as a lead in Regulatory Affairs across two or more major geographic areas
• Thorough understanding of drug development processes and regulatory requirements
• Regulatory experience with pre and post approval lifecycle management and leading cross-functional regulatory teams