Job Title:
Regulatory Data & Systems Manager
Location:
India – Hyderabad
Job ID:
R-229091
Work Location Type:
On Site
Date Posted:
November 03, 2025
Job Category:
Regulatory Affairs
Position Overview
The Regulatory Data & Systems Manager is responsible for managing and optimizing regulatory IT systems while ensuring compliance with industry and Amgen standards.
This role combines system administration, regulatory business analysis, and project coordination, playing a key part in facilitating communication and efficiency between regulatory, IT, and project teams.
The ideal candidate will possess a strong background in system analysis, regulatory operations, and project management, with demonstrated expertise in Veeva Vault and familiarity with GxP-compliant systems.
Key Responsibilities
1. System Administration
Manage and maintain Amgen’s regulatory IT systems to ensure security, efficiency, and compliance.
Support system configuration, user management, access control, and validation documentation.
Troubleshoot system issues and coordinate resolutions with IT and vendors.
2. Regulatory Business Analysis
Interpret, implement, and document regulatory system requirements in line with industry standards and Amgen processes.
Ensure all systems and workflows adhere to global regulatory guidance and best practices.
Support data quality, integrity, and governance for regulatory submissions.
3. Project Coordination
Assist in planning, tracking, and executing regulatory data and system projects.
Coordinate with project managers, QA, and technical teams to meet timelines.
Support change management and continuous improvement initiatives.
4. Stakeholder Communication
Act as a liaison between regulatory affairs, IT, and external vendors.
Ensure timely and accurate communication on system updates, compliance expectations, and project milestones.
Build strong relationships with cross-functional partners to drive collaboration and alignment.
Required Knowledge & Skills
Strong interpersonal and teamwork skills; able to collaborate effectively in a matrix organization.
Minimum 5 years’ experience as a Business Analyst or in a similar role.
Solid understanding of business analysis tools, SDLC, and Agile methodologies.
Excellent oral and written communication; capable of presenting complex information clearly.
Knowledge of GxP requirements and validated systems.
Experience in Life Sciences, Biotech, or Pharmaceutical industries.
Proven working knowledge of Veeva Vault.
Preferred Knowledge & Skills
Advanced expertise in Veeva Vault administration and configuration.
Familiarity with global regulatory submission processes and data standards.
Proficiency in Agile frameworks (Scrum, Kanban) for managing collaborative projects.
Practical experience with regulatory data standards (e.g., IDMP).
Experience managing enterprise-scale systems in a biotech/pharma environment.
Education & Experience
Basic Qualifications
Bachelor’s degree with 2+ years of directly related experience, OR
Associate’s degree with 6+ years of related experience, OR
High school diploma / GED with 8+ years of related experience.
Preferred Qualifications
5+ years of experience managing large-scale regulatory systems.
Demonstrated experience with regulatory data modeling 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.
Amgen ensures reasonable accommodations are available for individuals with disabilities during all stages of employment — from application and interview to job performance and benefits.
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