Job Title:
Regulatory Data & Systems Senior Associate
Location:
Hyderabad, India
Job ID: R-206527
Work Location Type: On Site
Date Posted: May 28, 2025
Category: Regulatory
About the Role:
Amgen is looking for a Regulatory Data & Systems Senior Associate to join our Regulatory Affairs team in Hyderabad. In this position, you will contribute to the execution and optimization of data systems that support regulatory submissions to health authorities. You’ll play a critical role in ensuring data compliance, system integrity, and operational efficiency using industry best practices and Amgen’s regulatory processes.
Key Responsibilities:
Data Administration & AI: Optimize and maintain complex regulatory data models for compliance, integration, and efficiency.
Regulatory Business Analysis: Interpret and implement evolving global regulatory requirements into systems and processes.
Project Coordination: Support project planning, tracking, and execution for regulatory initiatives.
Stakeholder Communication: Collaborate with internal/external partners to align on regulatory system updates and ensure accurate communication.
Required Knowledge & Skills:
5+ years of business analysis experience in a regulated industry.
Strong command of business analysis techniques, SDLC, Agile methodologies.
Exceptional communication and presentation skills.
Ability to navigate a matrix organization and work independently.
Understanding of GxP requirements and system validation in regulated environments.
Industry experience in biotech, pharmaceuticals, or life sciences.
Preferred Knowledge & Skills:
Advanced experience with Veeva Vault platforms.
Familiarity with global regulatory data standards and submission processes.
Understanding of IDMP, machine learning, or data management principles.
Proficiency with Scrum, Kanban, or other Agile frameworks.
Education & Experience:
Minimum qualifications (any one of the following):
Bachelor’s degree + 2 years of directly relevant experience
Associate’s degree + 6 years of experience
High school diploma / GED + 8 years of experience
Preferred:
5+ years of experience in regulatory data management, AI, or machine learning
Hands-on familiarity with regulatory standards such as IDMP (Identification of Medicinal Products)
Equal Opportunity Statement:
Amgen is an Equal Opportunity employer and considers all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran, or disability status. Reasonable accommodation is available for applicants during the hiring process.
Apply Now:
https://careers.amgen.com/job/R-206527/regulatory-data-systems-senior-associate-hyderabad-india
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