Regulatory Compliance Change Assessor - Manager

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.

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 staffs career development
• Identifies and implements process improvements for the change management process

We are all different, yet we all use our unique contributions to serve patients. The [vital attribute] professional we seek is a [type of person] with these qualifications.

Basic Qualifications:

• Doctorate degree OR
• Masters degree and 4 to 6 years of manufacture, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industry OR

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• Bachelors 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

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.