Regulatory Compliance Change Assessor - Manager

Career Category

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] professional 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

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

What you can expect of us

As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way.

In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.

Apply now

for a career that defies imagination

Objects in your future are closer than they appear. Join us.

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