Career Category
Regulatory
Job Description
Let’s do this. Let’s change the world. 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.
Roles & Responsibilities:
Key responsibilities of the Regulatory Manager 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
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
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The [vital attribute] skilled we seek is a [type of person] with these qualifications.
Basic Qualifications:
Doctorate degree OR
Master’s degree and 4 to 6 years of manufacture, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industry OR
Bachelor’s degree and 6 to 8 years of manufacture, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industry OR
Diploma and 10 to 12 years of manufacture, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industry