Amgen - Senior Associate - Regulatory Compliance Change Assessor

Job 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 strategie.

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

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