Senior Regulatory Writing Manager - Remote Submissions

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

Benefits offered by this job

Flexible work model

Remote work where possible

Job summary

Amgen is seeking a Regulatory Writing Senior Manager to lead the regulatory writing activities for complex product submissions and act as the functional area lead on cross-functional product teams. You will mentor junior writers, supervise contractors, and oversee timelines for submissions and related documents.

Ideal candidates have extensive regulatory writing experience in biotech/pharma, strong leadership skills, and the ability to manage multiple projects under SOPs and regulatory

Qualifications

• Doctorate or equivalent with 2+ years related experience or
• Master’s with 6+ years related experience or
• Bachelor’s with 8+ years related experience or
• Associate’s with 10+ years related experience or
• High school diploma with 12+ years related experience

Responsibilities

• Lead authoring or oversight of regulatory submission documents including CSRs, IBs, and eCTD materials
• Review and approve drafted documents per SOPs
• Lead writing activities for complex submissions (NDA/BLAs) with limited supervision
• Serve as functional area lead on product teams and provide input for Global Regulatory Plans
• Supervise contract/freelance writers and mentor junior medical writers
• Drive departmental and cross-departmental initiatives and timelines

Skills

Regulatory writing leadership

Mentoring

Cross-functional collaboration

Regulatory submissions

Education

Doctorate degree

Master’s degree

Bachelor’s degree

Associate’s degree

High school diploma / GED

Tools

eCTD knowledge

Job description

Amgen is seeking a Regulatory Writing Senior Manager to lead the regulatory writing activities for complex product submissions and act as the functional area lead on cross-functional product teams. You will mentor junior writers, supervise contractors, and oversee timelines for submissions and related documents.

Ideal candidates have extensive regulatory writing experience in biotech/pharma, strong leadership skills, and the ability to manage multiple projects under SOPs and regulatory