Job Title:
Senior Manager, Global Regulatory Writing
Job Details:
Job ID: R-222090
Location: India – Hyderabad
Work Type: On-site
Date Posted: August 28, 2025
Category: Regulatory
Company: Amgen
About Amgen:
Amgen has pioneered biotechnology since 1980, focusing on six therapeutic areas: Oncology, Inflammation, Obesity, General Medicine, Biosimilars, and Rare Disease. Our mission is to serve patients living with serious illnesses by researching, manufacturing, and delivering innovative medicines that help people live longer, fuller, and happier lives. Amgen offers a collaborative, innovative, and science-based culture to help you thrive while making a meaningful impact.
Role Overview:
The Senior Manager of Global Regulatory Writing will prepare and oversee the creation of regulatory submission documents that comply with global regulatory standards. This leadership role involves managing writing teams, ensuring quality, and supporting regulatory submission strategies across various clinical phases.
Key Responsibilities:
Prepare and oversee preparation of regulatory submission documents compliant with global standards
Write or supervise writing of clinical study reports and Investigator Brochures for all clinical phases (1-4)
Write CTD sections including Summary of Clinical Efficacy, Safety, Pharmacology, Biopharmaceutics, Clinical Overview, Table of All Studies, briefing documents, and safety documents across therapeutic areas and biosimilars
Prepare other regulatory submission documents such as RTQs, PIP, white papers, breakthrough therapy applications, and orphan drug applications
Manage study timelines and regulatory submission strategies
Act as a functional area representative and lead on product teams
Manage, train, and mentor medical writers and Global Regulatory Writing (GRW) staff
Assist with hiring, resourcing therapeutic areas, project teams, and departmental governance
Ensure high quality of regulatory submission documents at all development stages
Provide expertise on document design and good medical writing principles
Participate in departmental and cross-departmental meetings and initiatives
Basic Qualifications:
Doctorate degree with 13-15 years of experience in writing regulatory or scientific submission/documents
OR
Master’s degree with 15-17 years of experience in writing regulatory or scientific submission/documents
OR
Bachelor’s degree with 16-18 years of experience in writing regulatory or scientific submission/documents
Preferred Qualifications:
BS, MS, or higher degree in biology, chemistry, or related scientific discipline
Experience in writing clinical and regulatory documents
Strong negotiation, persuasion, collaboration, and analytical judgment skills
Ability to analyze medical data and interpret significance
Advanced knowledge of scientific/technical writing, editing, and regulatory guidance (e.g., ICH)
Advanced written and oral communication skills with strong attention to detail
Understanding of scientific/technical principles, concepts, theories, and standards
Strong time and project management skills with a results-driven mindset
Experience managing and supervising teams
Leadership skills in team environments
Experience mentoring, training, and directing others
What You Can Expect from Amgen:
Support for professional and personal growth and well-being
Competitive benefits and collaborative culture
Comprehensive Total Rewards Plans aligned with local industry standards
Equal Opportunity Statement:
Amgen is an Equal Opportunity employer and considers all qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.
Reasonable accommodations are provided to individuals with disabilities to support participation in the hiring process and employment. Please contact Amgen to request accommodations.
Apply Now
For a career that defies imagination: careers.amgen.com
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