Senior Regulatory Affairs Specialist – Global Submissions

Regulatory Jobs; United States; Hybrid; USD 84,000 - 114,000; Full time

Benefits offered by this job

Total Rewards Plan

Robust health, dental, and vision

Job summary

Amgen in the United States is seeking a Senior Associate in Regulatory Affairs to help ensure products meet regulatory standards and support submissions to agencies. You will work with regional leads to maintain regulatory histories, prepare submissions, and help shape regulatory strategies across multiple therapeutic areas.

Your role involves coordinating regulatory documents, maintaining compliance, and contributing to process improvements while benefiting from Amgen's Total Rewards Plan and

Qualifications

• Master’s degree in a relevant field.
• Bachelor’s degree with 2 years of Regulatory Affairs experience.
• Associate’s degree with 6 years of Regulatory Affairs experience.
• High school diploma / GED with 8 years Regulatory Affairs experience.

Responsibilities

• Assist Regional Regulatory Lead to support regional regulatory activities.
• Provide and maintain IND/MA documentation support in collaboration with Regional Regulatory Lead.
• Create and maintain product regulatory history documents through RIM and archive communications.
• Review GRSP regional input and support regulatory deliverables with leadership input.
• Prepare supportive documentation for regulatory deliverables and regulatory strategy.

Skills

Regulatory submissions experience

Regulatory strategy

Education

Master’s degree

Bachelor’s degree in Life Sciences

Bachelor’s degree

Associate’s degree

Job description

Amgen in the United States is seeking a Senior Associate in Regulatory Affairs to help ensure products meet regulatory standards and support submissions to agencies. You will work with regional leads to maintain regulatory histories, prepare submissions, and help shape regulatory strategies across multiple therapeutic areas.

Your role involves coordinating regulatory documents, maintaining compliance, and contributing to process improvements while benefiting from Amgen's Total Rewards Plan and