Regulatory Data & Systems Manager – Hyderabad, India
Category: Regulatory | Work Type: On-Site | Job ID: R-229091
Amgen is seeking a highly skilled Regulatory Data & Systems Manager to support global regulatory operations by managing core regulatory systems, ensuring compliance, and streamlining cross-functional processes. This role requires strong expertise in system administration, regulatory business analysis, and project coordination within the life sciences sector.
This position is based in Hyderabad, India, and offers an excellent opportunity to contribute to world-class regulatory excellence within a leading biotechnology organization.
Position Overview
The Regulatory Data & Systems Manager will oversee system administration activities, interpret regulatory requirements, and collaborate with internal stakeholders to ensure seamless regulatory submissions and compliance. The ideal candidate should possess strong analytical abilities, proven regulatory understanding, and hands-on experience in enterprise regulatory platforms.
Key Responsibilities
System Administration
Manage, maintain, and optimize enterprise IT and regulatory systems.
Ensure all systems comply with global regulatory standards and internal quality requirements.
Regulatory Business Analysis
Interpret regulatory guidelines and determine system and process requirements.
Translate regulatory needs into actionable system enhancements aligned with industry best practices.
Project Coordination
Support end-to-end project planning, tracking, and implementation across regulatory operations.
Coordinate departmental initiatives while ensuring adherence to timelines and quality standards.
Stakeholder Communication
Collaborate with cross-functional teams, vendors, and business users.
Communicate regulatory requirements, system updates, and project progress clearly and effectively.
Required Knowledge, Skills & Experience
Minimum 5+ years of experience as a Business Analyst with strong command of BA tools, SDLC, and Agile methodologies.
Proven experience with Veeva Vault and system administration.
Strong written and verbal communication skills with the ability to present ideas clearly.
Ability to work independently and within a matrixed environment.
Familiarity with GxP requirements and system validation.
Experience in Life Sciences, Biotech, or Pharmaceutical industries preferred.
Strong interpersonal skills with the ability to work across technical and non-technical teams.
Preferred Skills
Advanced proficiency in Veeva Vault systems.
Working knowledge of global regulatory processes and standards.
Experience with Agile frameworks such as Scrum or Kanban.
Understanding of regulatory data standards (e.g., IDMP).
Experience supporting large-scale enterprise systems in Biotech/Pharma (5+ years preferred).
Education Requirements
Minimum Qualifications:
Bachelor’s degree with 2+ years of directly related experience
OR
Associate’s degree with 6+ years of directly related experience
OR
High school diploma / GED with 8+ years of directly related experience
Preferred Qualifications:
Practical experience with regulatory data standards such as IDMP.
Advanced experience managing regulatory systems in the pharmaceutical or biotechnology industry.
Equal Opportunity Statement
Amgen is an Equal Opportunity Employer. All qualified applicants will be considered without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability. We also provide reasonable accommodations throughout the hiring process and employment lifecycle.
Apply Now
Begin your journey with a leading global biotechnology company committed to innovation, compliance, and patient-centric excellence.
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