Regulatory Compliance Change Assessor - Manager

To ensure appropriate regulatory oversight and evaluation of reportability for changes throughout product lifecycle. Regulatory Affairs, Chemistry, Manufacturing and Controls (RA CMC) facilitates product development and global registration by developing and executing regulatory strategies and managing effective regulatory agency interactions for product manufacturing and quality programs throughout product lifecycle.

Amgens Regulatory Compliance team is seeking to expand its capacity in India. The Regulatory Compliance team performs assessment of operational changes for regulatory reportability and maintenance of state and federal licenses for Amgen products across phases of development, modality, and countries.

The Change Assessor 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.

• 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 regulatorystrategies
• Provides expertise and guidance to interdepartmental and cross-functional teams
• Coaches and supports junior regulatory staffs career development
• Identifies and implements process improvements for the change management process

Doctorate degree OR Masters degree and 3 years of experience in manufacture, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industry OR Bachelors degree and 5 years of experience in manufacture, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industry