U.S. Regulatory Manager

Job Summary

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

Key Responsibilities

• Execute U.S. regulatory strategy and manage regulatory submissions aligned with global filing plans
• Implement product-related regulatory tactics and ensure ongoing regulatory compliance for assigned products
• Support Health Authority interactions and partner with cross-functional teams for alignment and execution

Required Qualifications

• Doctorate degree, or Master's degree with 2 years of experience, or Bachelor's degree with 4 years of experience, or Associate's degree with 8 years of experience, or High school diploma/GED with 10 years of experience
• Experience with regulatory submissions and interacting with regulatory agencies (FDA)
• Working knowledge of U.S. legislation/regulations relating to medicinal products
• Understanding of drug development and U.S. registration pathways
• Experience supporting regulatory strategy in obesity or related therapeutic areas