Regulatory Compliance Change Assessor

3 weeks ago


Hyderabad Telangana, India Amgen Full time

Career Category Regulatory ABOUT AMGEN Amgen harnesses the best of biology and technology to fight the world s toughest diseases and make people s lives easier fuller and longer We discover develop manufacture and deliver innovative medicines to help millions of patients Amgen helped establish the biotechnology industry more than 40 years ago and remains on the cutting-edge of innovation using technology and human genetic data to push beyond what s known today 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 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 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 regulatory strategies Provides expertise and guidance to interdepartmental and cross-functional teams Coaches and supports junior regulatory staff s career development Identifies and implements process improvements for the change management process Doctorate degree OR Master s degree and 3 years of experience in manufacture QA QC or regulatory CMC in the Pharmaceutical Biotechnology industry OR Bachelor s degree and 5 years of experience in manufacture QA QC or regulatory CMC in the Pharmaceutical Biotechnology industry EQUAL OPPORTUNITY STATEMENT Amgen is an Equal Opportunity employer and will consider you without regard to your race color religion sex sexual orientation gender identity national origin protected veteran status or disability status We will ensure that individuals with disabilities are provided with reasonable accommodation to participate in the job application or interview process to perform essential job functions and to receive other benefits and privileges of employment Please contact us to request an accommodation



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