US Regulatory Affairs Lead

Job Summary

As a full-time remote US Regulatory Affairs Lead, the successful candidate will manage regulatory strategies for assigned Amgen products, ensuring compliance with local and corporate standards while acting as the primary contact with regulatory agencies.

Key responsibilities

• Plan and execute regulatory submissions in alignment with corporate standards and local regulatory requirements
• Provide local input to global regulatory strategies and ensure timely submissions for product approvals
• Act as the point of contact with regulatory agencies and monitor changes in local legislation impacting regulatory compliance

Required qualifications

• Doctorate degree OR Master's degree with 3 years of US Regulatory experience OR Bachelor's degree with 5 years of US Regulatory experience OR Associate's degree with 10 years of US Regulatory experience OR High school diploma/GED with 12 years of US Regulatory experience
• Experience directly managing people or leading teams and projects
• Understanding of drug development and regulatory principles
• Experience with regulatory submissions and interactions with agencies such as the FDA
• Knowledge of U.S. legislation and regulations related to medicinal products