Regulatory Compliance Change Assessor (Senior Associate)
Location: Hyderabad, India
Category: Regulatory Affairs – Chemistry, Manufacturing and Controls (RA CMC)
Work Type: On-Site
Job ID: R-227866
About the Role
Amgen is expanding its Regulatory Compliance function in India and is seeking a skilled Regulatory Compliance Change Assessor (Senior Associate) to support global product development and lifecycle management. This role will be responsible for evaluating operational changes, determining regulatory reportability, and ensuring compliance across products and geographies.
As part of the Regulatory Affairs CMC team, you will collaborate with Global, Site, Biosimilars, and Device RA CMC teams, along with Operations, Quality, and Supply Chain stakeholders. You will contribute to change control processes, regulatory strategy alignment, and documentation within the change management system.
Key Responsibilities
Conduct assessments of change records to determine regulatory impact, reportability, and product distribution restrictions for assigned products.
Define, document, and maintain reporting requirements in the change control management system.
Collaborate with cross-functional teams, including Process Development, Operations, Quality, and Supply Chain, to ensure regulatory compliance alignment.
Provide expert guidance to internal and cross-functional partners on regulatory expectations.
Identify opportunities and implement process improvements within the change management workflow.
Qualifications and Experience Required
Basic Qualifications
Candidates must meet one of the following:
Master’s degree, OR
Bachelor’s degree with minimum 2 years of experience in manufacturing, QA/QC, or Regulatory CMC within the Pharmaceutical/Biotechnology industry, OR
Associate’s degree with minimum 6 years of experience in manufacturing, QA/QC, or Regulatory CMC in the Pharmaceutical/Biotechnology industry.
Preferred Qualifications
Degree in a Life Sciences discipline.
Strong knowledge and practical experience in Regulatory CMC.
Experience in pharmaceutical or biotech manufacturing, quality testing (QA/QC), clinical operations, or distribution.
Why Join Amgen?
Amgen is committed to upholding the highest ethical standards across its global operations. We value integrity, transparency, and adherence to regulatory practices that ensure patient safety and product quality.
Apply Now
If you meet the required qualifications and are looking to advance your regulatory career with a leading biotechnology organization, apply today.
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