U.S. Regulatory Lead - Obesity

Job Summary

A company is looking for a United States Regulatory Lead - Obesity and Related Conditions TA.

Key Responsibilities

• Execute U.S. regulatory strategy and represent the region on global governance teams
• Plan and lead U.S. regulatory submissions in alignment with global filing plans and U.S. requirements
• Lead U.S. regulatory document development and ensure ongoing regulatory compliance for assigned products

Required Qualifications

• Doctorate degree and 2 years of related experience, or Master's degree and 6 years, or Bachelor's degree and 8 years, or Associate's degree and 10 years of directly related experience
• Experience with regulatory submissions and interactions with regulatory agencies (FDA)
• Strong knowledge of the U.S. regulatory environment and drug development lifecycle
• Experience in developing regulatory strategy and risk management
• Experience supporting programs in Obesity, Diabetes, or related metabolic diseases