Career Category

Regulatory

Job Description

The Global Submission and Information Management (GSIM) team brings strategic technical expertise to drive operational excellence, innovation, and technical compliance for Amgen's global regulatory submission and information management. GSIM ensures smooth, compliant data flows among functional areas, external partners, and regulatory authorities while designing and implementing process improvements, digital technologies, data standards, and organizational change management to achieve business results.

The Senior Associate, Regulatory Data and Analytics role will support the execution of Amgen’s strategic approach towards Regulatory Affairs analytics, Data Standards, and emerging Data Standard compliance. The role involves contributing to Data and Analytics activities within AIN, collaborating with cross-functional and executive level stakeholders who utilize Regulatory and Master data across processes and systems. This role will support the delivery of key analytics, reporting, and insights.

Roles & Responsibilities:

• Integrate, clean, and prepare data from diverse systems including but not limited to Data Lakes, Data Warehouses, Databricks, Veeva RIMS / Veeva Vault etc.
• Apply statistical methods or machine learning techniques to support analysis & predictions across product lifecycle milestones
• Develop and maintain executive-level dashboards focused on product lifecycle milestones, enabling trend analysis, risk identification, and informed decision-making at the leadership level
• Delivering quality and compliance in global regulatory data analytics services across processes and systems
• Aid alignment with international data standards to ensure compliance with Health Authority regulations for submission and registration
• Execute and deliver on identified Regulatory Data & Analytics requirements in collaboration with stakeholders
• Contribute to implementation of strategy aimed at alignment with new and existing Regulatory Data Standards, Analytics, and Reporting
• Deliver against defined standards to scale data and usage with repeatable processes to keep data up to date
• Leverage global regulations to support system and process simplification, automation and innovation
• Organize and present data in user friendly, graphical, interactive informational summaries that illustrate how GRAAS is performing and allow us to understand and improve business performance

Required Knowledge and Skills:

• Strong knowledge of data analytics, data visualization, data storytelling and reporting
• Demonstrated experience supporting data and analytics initiatives
• Experience in delivering data-centric processes and systems
• Strong Knowledge of working with and handling structured and unstructured data
• Demonstrated ability to support change management and stakeholder engagement in a regulated environment

Preferred Knowledge and Skills:

• Strong understanding of Regulatory Affairs business complexity and process interdependencies
• Experience with regulatory master data in Regulatory Affairs, Research, Development, Quality Management, or related area
• Demonstrated experience in collaborating with high-performing teams
• Proficiency in data visualization tools or packages, such as Power BI in addition to data pipeline automation tools including Amazon Web Services (AWS), Databricks, Python, SQL etc.
• Strong understanding of web-app development to further support build and delivery of web-based analytical systems, such as web-based dashboards

Basic Education and Experience:

• Doctorate degree and 2 years of regulatory systems and data experience OR
• Master’s degree and 4 years of regulatory systems and data experience OR
• Bachelor’s degree and 5 years of regulatory systems and data experience OR
• Associate’s degree and 8 years of regulatory systems and data experience OR
• High school diploma / GED and 8+ years of regulatory systems and data experience

Preferred Education and Experience:

• Experience supporting data strategy initiatives across a large enterprise
• Understanding of KPI tracking and contributing to deliverables
• 4+ years’ experience in Regulatory Affairs

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