Regulatory Affairs Manager

Job Summary

To support regulatory compliance for Amgen's products, the full-time remote Regulatory Affairs Manager will manage US regulatory activities, serve as the point of contact with regulatory agencies, and oversee local regulatory submissions and product compliance.

Key responsibilities

• Support the Global Regulatory Team in US Regulatory Activities, including IND development and submission
• Act as the primary liaison with regulatory agencies and provide guidance on local regulatory strategies
• Plan and manage local regulatory submissions in compliance with corporate standards and local requirements

Required qualifications

• Doctorate degree, or Master's degree with 2 years of Regulatory Affairs 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 in Regulatory Affairs
• Preferred Master's degree in biology, life science, health science, or regulatory science with a biology focus
• Experience in a regulated industry, science, or clinical practice
• Strong organizational skills and ability to adapt to changes in product activity