Senior Regulatory Writing Lead - Remote

Amgen Inc.; United States; Hybrid; USD 140,000 - 189,000; Full time

Benefits offered by this job

Remote work arrangements

Job summary

Amgen seeks a Regulatory Writing Senior Manager in the United States to lead complex regulatory submissions and oversee writing activities. You will mentor junior writers and coordinate with product teams (GRL, Evidence Generation, Safety, Labeling) to ensure timely delivery.

The role emphasizes supervising contract writers, generating timelines, and advancing regulatory plans with strong leadership and communication skills.

Qualifications

• Doctorate, Master’s, Bachelor’s, Associate, or high school with required years of experience.
• Experience with regulatory documents in Regulatory Affairs or related areas.
• Ability to lead complex regulatory writing projects and teams.

Responsibilities

• Lead writing for complex product submissions and regulatory documents.
• Supervise contract and freelance writers; mentor junior writers.
• Serve as functional area lead on cross‑functional teams.
• Generate document timelines and manage schedules.
• Contribute to Global Regulatory Plan and team goals.

Skills

Regulatory writing

Leadership

Mentoring

Education

Doctorate degree

Master’s degree

Bachelor’s degree

Associate’s degree

High school diploma

Job description

Amgen seeks a Regulatory Writing Senior Manager in the United States to lead complex regulatory submissions and oversee writing activities. You will mentor junior writers and coordinate with product teams (GRL, Evidence Generation, Safety, Labeling) to ensure timely delivery.

The role emphasizes supervising contract writers, generating timelines, and advancing regulatory plans with strong leadership and communication skills.