Latest Job opportunities at AMGEN as a Sr Associate in Regulatory Compliance Change Assessor
About the Company:
Amgen is a leading global biotechnology company headquartered in Thousand Oaks, California. Founded in 1980, it focuses on discovering, developing, manufacturing, and delivering innovative medicines for serious diseases. The company primarily works in areas such as oncology, cardiovascular disease, inflammation, bone health, and rare diseases
It is dedicated to transforming patients’ lives worldwide through innovative medicines. With a strong focus on research and development, Amgen is committed to delivering high-quality therapies to address unmet medical needs around the world.
Job Posting: Regulatory Compliance Change Assessor – Sr Associate
Location: India – Hyderabad
Work Location Type: On Site
Date Posted: Mar. 10, 2025
Category: Regulatory
Roles & Responsibilities:
- Reviews change records to evaluate impact of the change with respect to reportability and product restrictions for any product in scope.
- Defines and documents the reporting and product distribution restriction requirements for the change within the change control management system.
- Liaise with other functions, including Process Development, Operations, Quality and Supply Chain to ensure alignment of regulatory strategies.
Basic Qualifications:
- Master’s degree OR
- Bachelor’s degree and 2 years of manufacture, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industry OR
- Associate’s degree and 6 years of manufacture, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industry OR
- Diploma and 8 years of manufacture, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industry
Preferred Qualifications:
- Degree in Life Science discipline
- Regulatory CMC specific knowledge & experience
- Understanding and application of principles, concepts, theories and standards of scientific/technical field
- Experience in manufacture, testing (QC/QA or clinical), or distribution in Pharmaceutical/Biotech industry
Keywords: Regulatory Compliance Change Assessor, Sr Associate, Regulatory, Regulatory Compliance, Regulatory Strategies, Pharmaceutical, Biotechnology, Quality Control, Quality Assurance, Manufacturing, Regulatory CMC, Latest Job opportunities, AMGEN
