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Amgen Technology Private Limited logo
Regulatory Compliance Change Assessor - Manager Amgen Technology Private Limited

4.0 - 12.0 years

5 - 15 Lacs

Hyderabad, Telangana, India

On-site

We are seeking a Regulatory Compliance Change Assessor to interface with global, site, biosimilars, and device regulatory teams, as well as Amgen Operations, Quality, and Supply Chain. This role is responsible for the global reportability assessment of single or cross-product changes, ensuring that all product-related changes adhere to regulatory requirements. The ideal candidate will have extensive experience in regulatory CMC within the pharmaceutical or biotechnology industry. Roles & Responsibilities Change Assessment: Review change records to evaluate the impact of changes with respect to reportability and product restrictions. You will define and document the reporting and product dist...

Posted 3 months ago

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