[Skip to main content](#main-content) [OpenNash Jobs](https://jobs.opennash.com/) [Hiring report](/reports/hiring/) · [All Amgen jobs](https://jobs.opennash.com/companies/amgen/) · [Search jobs](/search/) Amgen · India - Hyderabad # Global Regulatory Writing Manager India - Hyderabad Manager or lead Legal & Compliance Listed on Amgen’s official careers site. Listed as of October 18, 2026. Check that it is still open and apply there. [Apply on Amgen’s careers site →](https://amgen.wd1.myworkdayjobs.com/Careers/job/India---Hyderabad/Global-Regulatory-Writing-Manager_R-203647) [OpenNash Jobs](https://jobs.opennash.com/) / [Amgen](https://jobs.opennash.com/companies/amgen/) / Global Regulatory Writing Manager ## Job description Career Category Regulatory ### Job Description Career Category: Regulatory Let’s do this. Let’s change the world. In this vital role you will maintain key business relationships with appropriate cross-functional product team members. As requested, this role may serve as functional area lead on product teams, manage (with supervision) writing activities for product submissions, train and mentor more junior writers, and assist with departmental activities. ### Roles & Responsibilities Author regulatory submission documents, as assigned, including Clinical Study Reports, Investigator Brochures, Responses to Questions, Protocols, Protocol Amendments, Informed Consent Forms, Table of All Studies, Clinical Overview Addenda, eCTD Module 2 Clinical Summary Documents, Briefing Documents, Pediatric Investigation - Plans, and other regulatory documents; Conduct the formal review and approval of authored documents, following applicable standard operating procedures; With considerable supervision, manage regulatory writing activities for product submissions, including new and supplemental drug applications/biologics license applications; Serve as functional area lead on product teams (e.g., Global Regulatory Team, Evidence Generation Team, Global Safety Team, Label Working Group) May provide functional area input for Global Regulatory - Plan and team goals May work with contract and freelance writers May participate in training and mentoring of junior medical writers May participate in departmental and cross-departmental initiatives, as appropriate. Generate document timelines, with team input Keep abreast of relevant professional information and technology What we expect of you We are all different, yet we all use our unique contributions to serve patients. The [vital attribute] professional we seek is a [type of person] with these qualifications. ### Basic Qualifications Doctorate degree OR Master’s degree and 4 to 6 years of directly related experience OR Bachelor’s degree and 6 to 8 years of directly related experience OR Diploma and 10 to 12 years of directly related experience Preferred Qualifications: Functional Skills: Proficiency with word processing and other Microsoft Office Programs Significant knowledge of scientific/technical writing and editing, and of overall clinical development process for new compounds; Ability to understand and follow complex standard operating procedures (SOP’s), guidance documents, and work instructions; Understanding and application of principles, concepts, theories and standards of scientific/technical field. Substantial knowledge and understanding of International Council on Harmonization (ICH) and Good Clinical Practice (GCP) guidance’s and requirements. ### Soft Skills Excellent written/oral communication skills and attention to detail Ability to effectively demonstrate leadership in a team environment which requires negotiation, persuasion, collaboration, and analytical judgment; Proficient time and project management skills. Self-starter with a drive and perseverance to achieve results What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way. In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards. Apply now for a career that defies imagination Objects in your future are closer than they appear. Join us. careers.amgen.com. ## At a glance - Posted by the employer: Not stated - First seen by OpenNash: Jul 10, 2026 - Last checked: Oct 18, 2026 - Listed for: 100 days - Location: India - Hyderabad[Apply on Amgen’s careers site →](https://amgen.wd1.myworkdayjobs.com/Careers/job/India---Hyderabad/Global-Regulatory-Writing-Manager_R-203647) ## More jobs at Amgen ### [Global Regulatory Writing – Senior Associate](https://jobs.opennash.com/companies/amgen/jobs/da2cb05cf4a7ceaea0d8/) India - Hyderabad ### [Manager - International Regulatory Lead](https://jobs.opennash.com/companies/amgen/jobs/f0ce9f43b534cab2b328/) India - Hyderabad ### [Manager Supply Chain Compliance](https://jobs.opennash.com/companies/amgen/jobs/b2d225191e89ad617a13/) India - Hyderabad ### [Regulatory Affairs Manager (CMC)](https://jobs.opennash.com/companies/amgen/jobs/1b7240ef3cdd44a80471/) India - Hyderabad ### [Regulatory Affairs Mgr](https://jobs.opennash.com/companies/amgen/jobs/f4bcf7840369f64cfc61/) India - Hyderabad ## Similar jobs at other companies ### [[Innovative Medicine] R&D, Medical Writer III, Japan Medical Writing, Regulatory Medical Writing, Global Development](https://jobs.opennash.com/companies/johnson-johnson/jobs/b11e5d5790255c59bf7a/) Johnson & Johnson · Chiyoda, Tokyo, Japan ### [Senior Regulatory Specialist I - Toxicology, Global Regulatory Affairs](https://jobs.opennash.com/companies/ecolab/jobs/a7f265c77c592a38c347/) Ecolab · Pune, Mahārāshtra, India ### [[Innovative Medicine] R&D, Senior Document Specialist, Document Publishing Solutions, Regulatory Medical Writing, Global Development](https://jobs.opennash.com/companies/johnson-johnson/jobs/f913740cd2c38cae94fb/) Johnson & Johnson · Chiyoda, Tokyo, Japan ### [Commercial & Investment Bank - Global Regulatory & Policy Management (GRPM)](https://jobs.opennash.com/companies/jpmorganchase/jobs/2991d5188f985dd9a4f2/) JPMorganChase · Singapore ### [Principal Regulatory Affairs Specialist (Global Clinical Trial Applications)](https://jobs.opennash.com/companies/thermo-fisher-scientific/jobs/75dd5c37a684a8e82c40/) Thermo Fisher Scientific · Remote, Serbia OpenNash lists jobs from employers’ own careers sites and does not handle applications. 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