U.S. Regulatory Strategy Manager

Job Summary

Supporting the Obesity and Related Conditions Therapeutic Area, the full-time remote U.S. Regulatory Strategy Manager will develop and execute U.S. regulatory strategies, manage regulatory submissions, and ensure compliance for clinical trials and marketed products.

Key responsibilities

• Execute U.S. regulatory strategy and manage submissions for assigned programs
• Implement product-related regulatory tactics in accordance with U.S. legislation and internal standards
• Provide regulatory guidance and maintain compliance for clinical trial authorizations and marketing applications

Required qualifications

• Doctorate degree or equivalent experience in a related field
• Experience directly managing people or leading teams/projects
• Regulatory submissions experience and familiarity with FDA interactions
• Knowledge of U.S. legislation and regulations related to medicinal products
• Understanding of drug development and U.S. registration pathways