Reg Compliance Change Assessor

1 day ago

Hyderabad Telangana, India Amgen Full time

Career Category Regulatory 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 Amgen s Regulatory Compliance team is seeking to expand its capacity in India The Regulatory Compliance team performs assessment of operational changes for regulatory reportability 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 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 Provides expertise and guidance to interdepartmental and cross-functional teams 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 professional we seek is a type of person with these qualifications Basic Qualifications Master s degree OR Bachelor s degree and 2 years of manufacture QA QC or regulatory CMC in the Pharmaceutical Biotechnology industry OR Associate s degree and 6 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 Experience in manufacture testing QC QA or clinical or distribution in Pharmaceutical Biotech industry

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