Job Title:
Regulatory Compliance Change Assessor (Sr Associate)
Location:
India – Hyderabad
Job ID:
R-227866
Work Location Type:
On Site
Date Posted:
October 31, 2025
Category:
Regulatory Affairs
About the Role
The Regulatory Compliance Change Assessor (Sr Associate) supports Amgen’s Regulatory Affairs – Chemistry, Manufacturing, and Controls (RA CMC) organization, which ensures product development and registration success through effective regulatory strategies and agency interactions across the product lifecycle.
This role is part of the Regulatory Compliance Team, which performs global regulatory reportability assessments for operational changes affecting Amgen products. The position involves collaboration with Global RA CMC, Biosimilars, Device, Operations, Quality, and Supply Chain teams to ensure alignment and compliance.
The Change Assessor is responsible for evaluating manufacturing and operational changes, defining reporting requirements, and documenting product distribution restrictions — contributing to high-quality regulatory decision-making and global compliance.
Key Responsibilities
1. Regulatory Change Assessment
Review change records to assess impact on regulatory reportability and product restrictions across Amgen’s product portfolio.
Define and document regulatory reporting requirements and product distribution restrictions within the change control management system.
Conduct global assessments of changes (single or cross-product) to determine reporting obligations based on regional and product-specific requirements.
2. Cross-Functional Collaboration
Liaise with Process Development, Operations, Quality, and Supply Chain teams to ensure alignment with regulatory strategies.
Partner with Global RA CMC and site-level regulatory teams to clarify requirements and ensure consistency in global submissions.
3. Regulatory Strategy & Compliance
Provide guidance and expertise to interdepartmental teams regarding change assessment principles and best practices.
Support the Regulatory Compliance Team Lead in implementing process improvements, standardization, and operational excellence initiatives.
4. Process Improvement
Identify opportunities to streamline change management workflows and enhance regulatory data quality.
Contribute to continuous improvement of regulatory assessment and documentation practices.
What We Expect of You
Basic Qualifications
Master’s degree
OR
Bachelor’s degree with 2+ years of experience in manufacturing, QA/QC, or Regulatory CMC in the Pharmaceutical/Biotechnology industry
OR
Associate’s degree with 6+ years of related experience in manufacturing, QA/QC, or Regulatory CMC
Preferred Qualifications
Degree in a Life Science discipline (Pharmacy, Biotechnology, Chemistry, etc.)
Strong knowledge and experience in Regulatory CMC principles and processes
Experience in manufacture, quality control/assurance, testing, or distribution within the pharma/biotech industry
Ability to analyze regulatory impacts of technical changes and communicate findings effectively
Collaborative mindset and attention to detail in documentation and compliance
Equal Opportunity Statement
Amgen is an Equal Opportunity Employer and considers all qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, or disability.
We ensure that individuals with disabilities are provided reasonable accommodations during all stages of employment — from application and interview to performance and benefits.
Gujarat :
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Auckland |New Zealand :
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Tartu | Estonia |Harju County (Maakond) :
Tallinn |Hà Nội :
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