Senior Associate - Regulatory Affairs - Remote

Overview

The Senior Associate in Regulatory Affairs at Amgen plays an important role in ensuring that the company's products meet and maintain regulatory standards, assisting in preparing submissions for regulatory agencies and guiding teams to ensure compliance.

In Short

• Assist in preparing submissions for regulatory agencies.
• Ensure compliance with applicable regulations.
• Support US regulatory activities for IND, BLA, and NDA submissions.
• Maintain regulatory documentation and product history.
• Conduct regulatory research to support strategic plans.
• Coordinate the collection of functional documents for applications.
• Provide authorship to regulatory correspondence.
• Support process improvement and standards development.
• Participate in Global Regulatory Teams and assist with meeting management.
• Respond to FDA inquiries and manage documentation quality checks.

Requirements

• Master’s degree or Bachelor’s with 2 years of experience.
• Associate’s degree with 6 years of experience or High school diploma with 8 years of experience.
• Strong communication skills, both oral and written.
• Organizational skills and attention to detail.
• Experience in regulated industry, science, or clinical practice.

Benefits

• Comprehensive employee benefits package.
• Retirement and Savings Plan with generous contributions.
• Group medical, dental, and vision coverage.
• Flexible work models, including remote and hybrid options.
• Discretionary annual bonus program.