Instagram
youtube
Facebook

Senior Manager, Global Regulatory Writing

13-15 years years
Not Disclosed
10 Sept. 2, 2025
Job Description
Job Type: Full Time Education: 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 submissi Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

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