Senior Manager, Global Regulatory Writing
Location: Hyderabad, India
Job ID: R-222090
Work Location Type: On Site
Date Posted: Aug. 28, 2025
Category: Regulatory
About Amgen
At Amgen, you’re part of something bigger. Our shared mission—to serve patients living with serious illnesses—drives everything we do. Since 1980, we’ve pioneered breakthroughs in biotech to tackle the world’s toughest diseases.
With focus on six therapeutic areas—Oncology, Inflammation, Obesity, General Medicine, Biosimilars, and Rare Disease—we reach millions of patients each year. Join Amgen and make a lasting impact on patients’ lives while advancing your career in a collaborative, innovative, and science-based culture.
Role Summary
As Senior Manager, Global Regulatory Writing, you will play a critical role in preparing and overseeing the development of regulatory submission documents in compliance with global standards. You will lead medical writers, manage project timelines, and provide scientific and regulatory expertise to ensure high-quality submissions across all stages of clinical development.
Key Responsibilities
Prepare and oversee preparation of regulatory submission documents aligned with global standards.
Write or supervise the writing of:
Clinical Study Reports (CSRs)
Investigator Brochures (IBs)
CTD sections, including Summary of Clinical Efficacy, Safety, Pharmacology, Biopharmaceutics, Clinical Overview, Table of All Studies
Other regulatory documents: RTQs, PIP, white papers, breakthrough therapy applications, orphan drug applications.
Manage timelines for regulatory documents and submissions.
Serve as a functional area lead and represent regulatory writing on product teams.
Manage, train, and mentor medical writing staff.
Oversee GRW (Global Regulatory Writing) team workload.
Support departmental initiatives, hiring, resource planning, and governance.
Ensure quality of regulatory documents throughout product lifecycle.
Provide guidance on document design and best practices in medical writing.
Participate in cross-departmental initiatives and meetings as appropriate.
Basic Qualifications
Master’s degree in a relevant field.
13–17 years of experience in regulatory or scientific writing for submission documents.
Preferred Qualifications
Proven experience in writing clinical and regulatory documents.
Strong analytical skills for interpreting medical data.
Advanced knowledge of scientific/technical writing, regulatory guidance (e.g., ICH), and compliance standards.
Excellent written and verbal communication skills with strong attention to detail.
Strong time, project, and people management skills.
Experience mentoring, training, and supervising others.
Effective negotiation, collaboration, and leadership skills.
What We Offer
Competitive base salary and comprehensive Total Rewards Plans aligned with local industry standards.
Collaborative culture supporting professional and personal growth.
Opportunities to work on innovative projects that improve patients’ lives globally.
Diversity & Inclusion
Amgen fosters an inclusive environment of diverse, ethical, and accomplished individuals who live by our values. We are an Equal Opportunity Employer, considering all qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other legally protected basis.
Reasonable accommodations are available for individuals with disabilities to participate in the application, interview process, or perform essential job functions.
Apply Now: careers.amgen.com
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