Job highlights

- Bachelor s degree and 6 to 8 years of manufacture,QA / QC,or regulatory CMC in the Pharmaceutical / Biotechnology industry OR.
- 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

Career Category Regulatory 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] qualified 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

📌 Regulatory Compliance Change Assessor - Manager (Hyderabad)
🏢 Amgen
📍 Hyderabad