Global Regulatory Affairs Lead

Job Summary

A company is looking for a Global Regulatory Affairs Lead.

Key Responsibilities

• Interpret regulatory authority policies and apply them to product development and labeling activities
• Drive innovative approaches to regulatory submissions to enhance approval outcomes
• Collaborate with key opinion leaders and manage regulatory relationships with Health Authorities

Required Qualifications

• Bachelor's degree preferred; advanced degree (Masters, PhD, PharmD) preferred
• 10+ years in Regulatory Affairs or relevant experience in a regulated environment
• Experience managing global regulatory portfolios across regions such as the EU, AMEA, and Canada
• Solid understanding of regulatory processes and supporting information systems
• Demonstrated ability to influence and collaborate effectively with stakeholders