Senior Regulatory Writing Lead — Global Submissions

Regulatory Jobs; United States; Remote; USD 140,000 - 189,000; Full time

Job summary

Amgen is seeking a Regulatory Writing Senior Manager to lead and mentor writers, manage complex product submissions, and act as the regulatory writing lead on key product teams. You will guide document timelines, ensure quality, and influence global regulatory strategy.

The role focuses on cross-functional collaboration, training junior writers, and delivering high-quality submission documents within a fast-paced biotech environment.

Qualifications

• Regulatory writing experience in biotech/pharma is preferred.
• Experience leading regulatory writing teams and cross-functional collaboration.

Responsibilities

• Author or oversee the authoring of all regulatory submission documents including Clinical Study Reports, Investigator Brochures, Responses to Questions, Protocols, Protocol Amendments, Informed Consent Forms, Table of All Studies, Clinical Overview Addenda, eCTD Module 2 Clinical Summary Documents, Briefing Documents, and Pediatric Investigation Plans.
• Conduct the formal review and approval of authored documents, following applicable standard operating procedures.
• With limited supervision, lead regulatory writing activities for complex product submissions, including new and supplemental drug applications/biologics license applications.
• Serve as functional area lead on product teams (e.g., Global Regulatory Team, Evidence Generation Team, Global Safety Team, Label Working Group).
• Provide functional area input for Global Regulatory Plan and team goals.

Education

Doctorate degree

Master’s degree

Bachelor’s degree

Associate’s degree

High school diploma / GED

Job description

Amgen is seeking a Regulatory Writing Senior Manager to lead and mentor writers, manage complex product submissions, and act as the regulatory writing lead on key product teams. You will guide document timelines, ensure quality, and influence global regulatory strategy.

The role focuses on cross-functional collaboration, training junior writers, and delivering high-quality submission documents within a fast-paced biotech environment.