U.S. Regulatory Strategy Manager

Job Summary

Supporting products in the General Medicine Therapeutic Area, the full-time remote U.S. Regulatory Strategy Manager will develop and execute U.S. regulatory strategy, manage submissions, and ensure compliance with local laws and regulations to facilitate clinical trials and maintain commercial licenses.

Key responsibilities

• Execute U.S. regulatory strategy and manage regulatory submissions aligned with global filing plans
• Implement product-related regulatory tactics to ensure compliance with U.S. legislation and internal standards
• Communicate regulatory strategy within cross-functional teams and support Health Authority interactions

Required qualifications

• Doctorate degree OR Master's degree with 2 years of related experience OR Bachelor's degree with 4 years of related experience
• Experience with regulatory submissions and interactions with regulatory agencies (e.g., FDA)
• Knowledge of U.S. legislation and regulations related to medicinal products
• Understanding of drug development and U.S. registration pathways
• Experience in general medicine, metabolic disorders, or related therapeutic areas