Reg Compliance Change Assessor

12 hours ago

Hyderabad, Telangana, India Amgen Full time ₹ 12,00,000 - ₹ 36,00,000 per year

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 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.

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
  • Provides expertise and guidance to interdepartmental and cross-functional teams
  • Identifies and implements process improvements for the change management process

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

Preferred Qualifications:

  • Degree in Life Science discipline
  • Regulatory CMC specific knowledge & experience
  • Experience in manufacture, testing (QC/QA or clinical), or distribution in Pharmaceutical/Biotech industry

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