Regulatory Affairs Associate - US Submissions & Strategy

Amgen; United States; On-site; USD 110,000 - 140,000; Full time

Benefits offered by this job

Total Rewards Plan

Stock-based incentives

Retirement and savings plan

Flexible work models

Job summary

Amgen is seeking a Senior Associate in Regulatory Affairs to support US regulatory submissions under the guidance of the US Regulatory Lead and the Global Regulatory Team. You will help prepare, deliver, and archive regulatory documentation while interacting with the GRT and CROs as needed.

The role emphasizes strong communication, collaboration, and the ability to manage multiple regulatory activities in a fast-paced environment.

Qualifications

• Master’s degree is required.
• Bachelor’s degree with 2+ years Regulatory Affairs experience is acceptable.
• Associate’s degree with 6+ years Regulatory Affairs experience is acceptable.
• High school diploma/GED with 8+ years Regulatory Affairs experience is acceptable.

Responsibilities

• Coordinate and execute US regulatory submissions under the direction of the US Regulatory Lead.
• Manage preparation, delivery, and archiving of documents for US submissions.
• Assist Global Regulatory Lead to manage GRT interactions.
• Coordinate QC of regulatory documents and briefing materials.
• Provide primary authorship to routine regulatory correspondence.

Skills

Strong communication

Scientific/clinical information

Team collaboration

Cultural awareness

Planning and organizing

Prioritize multiple tasks

Adaptability to ambiguity

Influence others

Education

Master’s degree

Bachelor’s degree + 2 years Regulatory Affairs

Associate’s degree + 6 years Regulatory Affairs

High school diploma / GED + 8 years Regulatory Affairs

Job description

Amgen is seeking a Senior Associate in Regulatory Affairs to support US regulatory submissions under the guidance of the US Regulatory Lead and the Global Regulatory Team. You will help prepare, deliver, and archive regulatory documentation while interacting with the GRT and CROs as needed.

The role emphasizes strong communication, collaboration, and the ability to manage multiple regulatory activities in a fast-paced environment.