[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 # Sr. Associate Regulatory Affairs India - Hyderabad Senior individual contributor 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/Sr-Associate-Regulatory-Affairs_R-250844) [OpenNash Jobs](https://jobs.opennash.com/) / [Amgen](https://jobs.opennash.com/companies/amgen/) / Sr. Associate Regulatory Affairs ## Job description Career Category Regulatory ### Job Description Job Description: Amgen is a leading human therapeutics company in the biotechnology industry. For more than 40 years, the company has tapped the power of scientific discovery and innovation to advance the practice of medicine. As a Fortune 500 company serving millions of patients, Amgen continues to be an entrepreneurial, science-driven enterprise dedicated to helping people fight serious illness. Regulatory Affairs, Chemistry, Manufacturing and Controls (RA CMC) facilitates product development and global registration by developing and executing regulatory strategies and managing effective regulatory agency interactions for product manufacturing and quality programs throughout product lifecycle. Amgen’s CMC submission execution team, R egulatory O ptimization o f T actical and S trategic S upport (ROOTS2), is seeking to expand its capacity in India. The ROOTS2 team supports CMC and/or Device submission execution for Amgen products across phases of development, modality and countries. The ROOTS2 staff member will interface with the Amgen Global, Site, Biosimilars, and/or Device RA CMC teams for specific strategies or activities that impact a product. The ROOTS2 staff member will be responsible for varying levels of product support, including leading projects, based upon their experience level. Additional job responsibilities include: - Lead submission for annual reports, facility registrations, facility renewals, and product renewals Interact with authors/reviewers and subject matter experts with respect to delivery of CMC and/or Device documents required for regulatory submissions Preparing submission content plans for CMC submissions including, CMC IND/CTAs and amendments, Investigational Device Exemption (IDE)/Performance Study Application (PSA)/ Clinical Investigation Application (CIA), new marketing applications, facility registration and renewals, post‑market supplements/variations, product renewals, Module 3 baselines, and annual report/notifications Coordination, preparation, collection and/or legalization of CMC country specific documents - Document and archive CMC submissions and related communications in the document management system Initiate and maintain CMC product and/or Device timelines at the direction of product lead Interface with the regulatory operations team Train staff on select procedures and systems - Provide report status of activities and projects to teams and department - Participate in cross-functional special project teams Basic Qualifications: Bachelor’s degree and 5-9 years of experience in manufacture, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industry Preferred Qualifications: BS degree in Life Science Experience in manufacture, Process Development, Quality Assurance, Quality - Control, or Analytical development Experience in IVD, Device or Combination Product regulatory submission process Regulatory CMC specific knowledge and experience Mature project management and organizational skills - Strong and effective oral and written communication skills Experience in Veeva Vault platforms. ## At a glance - Posted by the employer: Not stated - First seen by OpenNash: Aug 21, 2026 - Last checked: Oct 18, 2026 - Listed for: 58 days - Location: India - Hyderabad[Apply on Amgen’s careers site →](https://amgen.wd1.myworkdayjobs.com/Careers/job/India---Hyderabad/Sr-Associate-Regulatory-Affairs_R-250844) ## More jobs at Amgen ### [Global Regulatory Writing Manager](https://jobs.opennash.com/companies/amgen/jobs/33aa8d1c63153bf19edf/) India - Hyderabad ### [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 ## Similar jobs at other companies ### [Senior Regulatory Specialist I - Toxicology, Global Regulatory Affairs](https://jobs.opennash.com/companies/ecolab/jobs/a7f265c77c592a38c347/) Ecolab · Pune, Mahārāshtra, India ### [Regulatory Affairs Specialist](https://jobs.opennash.com/companies/ecolab/jobs/2f207cd244cb549328ab/) Ecolab · Kraków, Poland ### [Principal Regulatory Affairs Professional](https://jobs.opennash.com/companies/thermo-fisher-scientific/jobs/3a8ef8a0559f4968a312/) Thermo Fisher Scientific · Remote, Mexico ### [Regulatory Affairs Specialist](https://jobs.opennash.com/companies/thermo-fisher-scientific/jobs/c80907ca1d5f566fcec5/) Thermo Fisher Scientific · Bangalore, Karnātaka, India ### [Utility Regulatory Affairs Senior Advisor](https://jobs.opennash.com/companies/edison-international/jobs/e65e0246ae95ee67c55a/) Edison International OpenNash lists jobs from employers’ own careers sites and does not handle applications. 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