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.
Key responsibilities of the Regulatory Sr Associate include:
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
We are all different, yet we all use our unique contributions to serve patients. The professional we seek is a type of person with these qualifications.
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