Remote Regulatory Writing Lead, Biotech Submissions

BioSpace; Washington (District of Columbia); On-site; USD 140,000 - 180,000; Full time

Job summary

Amgen is seeking a Regulatory Writing Senior Manager to serve as the functional area lead on product teams, leading writing activities for complex product submissions and mentoring junior writers. This role requires providing expertise across regulatory documents and coordinating with cross-functional teams.

Key responsibilities include authoring submission documents, supervising writers, and guiding timelines as part of Global Regulatory initiatives.

Qualifications

• Doctorate degree and 2 years of directly related experience.
• Masters degree and 6 years of directly related experience.
• Bachelor's degree and 8 years of directly related experience.
• Associates degree and 10 years of directly related experience.
• High school diploma / GED and 12 years of directly related experience.

Responsibilities

• Author or oversee the authoring of regulatory submission documents.
• Conduct formal review and approval of authored documents.
• Lead regulatory writing activities for complex submissions.
• Serve as functional area lead on product teams.
• Provide input for Global Regulatory Plans and team goals.
• Supervise contract and freelance writers and mentor junior writers.
• Lead departmental and cross-departmental initiatives.
• Generate document timelines.

Skills

Regulatory writing

Leadership

Mentoring

Education

Doctorate degree

Master's degree

Bachelor's degree

Associates degree

High school diploma

Job description

Amgen is seeking a Regulatory Writing Senior Manager to serve as the functional area lead on product teams, leading writing activities for complex product submissions and mentoring junior writers. This role requires providing expertise across regulatory documents and coordinating with cross-functional teams.

Key responsibilities include authoring submission documents, supervising writers, and guiding timelines as part of Global Regulatory initiatives.