Regulatory Compliance Change Assessor - Manager

Lets do this. Lets 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 staffs 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] 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

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