Senior Regulatory Compliance Change Assessor

Join Our Team as a Senior Regulatory Compliance Change Assessor and Play a Key Role in Driving Success in the Pharmaceutical/Biotechnology Industry! We are seeking a highly skilled and experienced professional to fill a remote Senior Regulatory Compliance Change Assessor position. As a Senior Regulatory Compliance Change Assessor, you will have the opportunity to work with a talented team and contribute to the development and implementation of regulatory strategies that impact products globally. This is a fantastic chance to take your career to the next level and make a meaningful difference in the lives of patients.

This remote position offers a competitive salary, comprehensive benefits, and the opportunity to work with a leading biotechnology company. If you have a strong background in regulatory compliance, a passion for driving success, and excellent communication skills, we encourage you to apply for this exciting opportunity.

Career Category: Regulatory

The Senior Regulatory Compliance Change Assessor will collaborate with cross-functional teams, including Amgen Global, Site, Biosimilars, and/or Device RA CMC teams, as well as Amgen Operations, Quality, and/or Supply Chain, to develop and implement regulatory strategies that drive success. The successful candidate will be responsible for assessing the impact of changes on product reportability and restrictions, defining and documenting reporting and product distribution requirements, and liaising with other functions to ensure alignment of regulatory strategies.

Key Responsibilities:

• Review change records to evaluate the impact of changes on product reportability and restrictions
• Define and document reporting and product distribution requirements within the change control management system
• Collaborate with cross-functional teams to ensure alignment of regulatory strategies
• Provide regulatory guidance and support to ensure compliance with regulatory requirements

What We Expect from You:

We are looking for a highly motivated and experienced professional with a strong background in regulatory compliance. The ideal candidate will have:

• A Master's degree or a Bachelor's degree with 2 years of experience in manufacture, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industry
• A degree in a Life Science discipline, with regulatory CMC specific knowledge and experience
• Understanding and application of principles, concepts, theories, and standards of scientific/technical fields
• Experience in manufacture, testing (QC/QA or clinical), or distribution in the Pharmaceutical/Biotech industry

About Amgen:

Amgen is a leading biotechnology company that discovers, develops, manufactures, and delivers innovative human therapeutics. Our approach begins with using advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology. We focus on areas of high unmet medical need and leverage our biologics manufacturing expertise to strive for solutions that improve health outcomes and dramatically improve people's lives.

Ready to Apply?

If you are a motivated and experienced professional looking for a new challenge, we encourage you to apply for this exciting opportunity. Please click the link below to submit your application.