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

About Amgen

Amgen harnesses the best of biology and technology to fight the world’s toughest diseases, and make people’s lives easier, fuller and longer. We helped establish the biotechnology industry, and we remain on the cutting-edge of innovation, using technology and human genetic data to push beyond what’s known today. Our investment in research and development has yielded a robust pipeline that builds on our existing portfolio of medicines to treat cancer, heart disease, osteoporosis, inflammatory diseases and rare diseases. Amgen is one of 30 companies comprising the Dow Jones Industrial Average®, and part of the Nasdaq-100 Index®. In 2024, Amgen was named one of the “World’s Most Innovative Companies” by Fast Company and one of “America’s Best Large Employers” by Forbes. For more information, visit Amgen.com and follow us on X, LinkedIn, Instagram, TikTok, YouTube and Threads. 🔗 Community Guidelines: https://wwwext.amgen.com/community-guidelines 🔗Global Privacy Statement Directory: www.amgen.com/dp Special Advisory: Please be cautious of scam recruitment offers claiming to be from Amgen. Such scams may come from various sources, including fake websites and/or unsolicited emails and seek to obtain personal data or payment from victims by offering jobs that do not exist. Please be advised that Amgen would never ask for payment to progress a job application. When in doubt, please check to see if the position in question is posted on this website before applying. Additionally, please report any suspicious recruiting activity to https://complaint.ic3.gov/ and thank you for your assistance.