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Regulatory Compliance Change Assessor - Sr Associate

Regulatory Compliance Change Assessor - Sr Associate

Amgen Inc

2 - 6 years

3 - 7 Lacs

Hyderabad

Posted:2 weeks ago| Platform:

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Skills Required

pharmaceutical regulatory regulatory compliance quality assurance regulatory affairs risk management fda project management usfda documentation auditing gmp pharmacovigilance ra ich ctd clinical research qms drug regulatory affairs clinical trials

Work Mode

Work from Office

Job Type

Full Time

Job Description

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: 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 OR Diploma and 8 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

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Amgen Inc

www.amgen.com

Biotechnology

Thousand Oaks

22,000 Employees

868 Jobs

Key People

Robert A. Bradway

Chairman & CEO
Murray Aitken

Senior Vice President
Peter H. Krammer

Executive Vice President
Christine J. Koury

Vice President, Principal Financial Officer

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Regulatory Compliance Change Assessor - Sr Associate

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