Regulatory Compliance Change Assessor - Sr Associate
Location: India - Hyderabad
Remote Type: On Site
Time Type: Full Time
Posted On: 16 Days Ago
Job Requisition ID: R-207693
Career Category: Regulatory
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:
Review change records to evaluate the impact of changes with respect to reportability and product restrictions.
Define and document 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 someone 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 fields
Experience in manufacture, testing (QC/QA or clinical), or distribution in the Pharmaceutical/Biotech industry
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