Description
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.
**Roles & Responsibilities:**
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
**What we expect of you**
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
