Regulatory Data & Systems Manager

Job Description

As the Regulatory Data & Systems Manager, you will oversee system administration and act as a critical liaison between regulatory, IT, and business teams. Your expertise will ensure that Amgen's regulatory systems are optimized, compliant, and aligned with industry best practices and evolving regulatory requirements. You will facilitate smooth communication and project coordination to support regulatory submissions and data integrity across the enterprise. Key Roles & Responsibilities System Administration: Manage and maintain regulatory IT systems, ensuring security, efficiency, and compliance with GxP and other regulatory standards. Regulatory Business Analysis: Interpret and implement regulatory requirements in collaboration with business and technical teams to maintain system compliance and process adherence. Project Coordination: Assist in planning, tracking, and executing departmental projects, ensuring alignment with regulatory timelines and goals. Stakeholder Communication: Act as a communication bridge between internal teams, external vendors, and service providers to ensure clear understanding and timely updates regarding regulatory requirements and system changes. Required Knowledge and Skills Strong interpersonal skills to engage effectively with business users, IT teams, project managers, senior leadership, vendors, and outsourced service providers. Minimum 5 years experience as a business analyst with expertise in business analysis tools, SDLC, and Agile methodologies. Excellent verbal and written communication skills with the ability to present ideas clearly and persuasively. Ability to thrive in a matrix organization; collaborative team player with the capability to work independently. Familiarity with GxP requirements and system validation processes. Experience in Life Sciences, Biotech, or Pharmaceutical industries preferred. Proven experience with Veeva Vault administration and functionality. Preferred Knowledge and Skills Advanced expertise with Veeva Vault systems administration. Understanding of global regulatory processes and standards. Proficiency in Agile frameworks such as Scrum and Kanban to support efficient and adaptable team workflows. Education and Experience Requirements Basic Qualifications: Bachelor's degree plus 2 years of relevant experience, OR Associate's degree plus 6 years of relevant experience, OR High school diploma/GED plus 8 years of relevant experience. Preferred Qualifications: Hands-on experience with regulatory data standards such as IDMP. 5+ years managing large-scale enterprise systems in Biotech or Pharmaceutical environments.