Regulatory Compliance Change Assessor - Sr Associate

Career Category

Regulatory

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 Sr Associate 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.

What we expect of you

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

Basic Qualifications :

Preferred Qualifications :

Locations : India - Hyderabad