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In this vital role you will report into the Regulatory Compliance Team lead. The Regulatory Compliance Change Assessor will interface with the Amgen Global, Site, Biosimilars, and/or Device RA CMC teams, as well as Amgen Operations, Quality, and/or Supply Chain for specific strategies or activities that impact a product. The Change Assessor will be responsible for varying levels of product support, including global reportability assessment of single or cross-product changes, based upon their experience level.
Job Responsibility:
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
Provides expertise and guidance to interdepartmental and cross-functional teams
Coaches and support junior regulatory staff’s career development
Identifies and implements process improvements for the change management process
Requirements:
Doctorate degree
Master’s degree and 4 to 6 years of manufacture, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industry
Bachelor’s degree and 6 to 8 years of manufacture, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industry
Diploma and 10 to 12 years of manufacture, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industry
Nice to have:
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
What we offer:
Competitive and comprehensive Total Rewards Plans that are aligned with local industry standards