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Regulatory Compliance Change Assessor - Manager

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Amgen

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Location:
India , Hyderabad

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Category:
-

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Contract Type:
Not provided

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Salary:

Not provided

Job Description:

In this vital role you 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.

Job Responsibility:

  • 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 support junior regulatory staff’s career development
  • Identifies and implements process improvements for the change management process

Requirements:

  • Doctorate degree
  • Master’s degree and 4 to 6 years of manufacture, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industry
  • Bachelor’s degree and 6 to 8 years of manufacture, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industry
  • Diploma and 10 to 12 years of manufacture, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industry

Nice to have:

  • 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
What we offer:

Competitive and comprehensive Total Rewards Plans that are aligned with local industry standards

Additional Information:

Job Posted:
February 13, 2026

Work Type:
On-site work
Job Link Share:

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