Senior Manager - Regulatory Data and Analytics

Career Category Safety Job Description Join Amgen’s Mission of Serving Patients At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do. Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. Senior Manager - Regulatory Data and Analytics What you will do 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. 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. Build and lead a successful team, focused on delivering global regulatory data analytics services across processes and systems. Ensure compliance with international data standards to ensure compliance with Health Authority regulations for submission and registration. Collaborate cross-functionally internally and externally with Global Regulatory Affairs and Strategy (GRAAS) to identify Regulatory Data and Analytics requirements. Lead Strategy development and implementation for new and existing Regulatory Data Standards, Analytics, and Reporting. Partner with Digital Technology and Innovation (DTI) Team to develop multi- year Data Standards, Management, and Analytics to increase Regulatory Data Visibility and insights. Increase data insight to make it easier for leadership to quickly and confidently find the right data for their business decisions. Set standards to scale data and usage with repeatable processes to keep (meta) 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. What we expect of you The Senior Manager of Regulatory Data and Analytics will help shape Amgen’s strategic approach towards Regulatory Affairs analytics, Data Standards and emerging Data Standard compliance. The role involves leading the Data and Analytics team in AIN, engaging with GSIM leadership and cross-functional partners who use Regulatory and Master data across processes and systems. This role is pivotal in building and leading an impactful team from the ground up, ensuring the delivery of key analytics and reporting. Basic Qualifications: Doctorate degree and 2 years of regulatory systems experience OR Master’s degree and 8 to 10 years of regulatory systems experience OR Bachelor’s degree and 10 to 14 years of regulatory systems experience OR Associate’s degree and 14 to 18 years of regulatory systems experience OR Advanced knowledge of Veeva Vault Proven leadership in regulatory data and analytics and reporting Proven experience of devising data-centric processes and systems. Strong Knowledge of handling structured and unstructured data Demonstrated excellence in change management and key customer engagement. Preferred Qualifications: 5+ years’ of proven experience in Regulatory Affairs. Experience with delivering data strategy across a large enterprise Ability to build compelling cases with accurate cost and effort estimations Excellent understanding of IDMP, 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 building and leading successful teams. Sharp learning agility and analytical thinking Proficiency in data visualization tools or packages, such as Tableau or Spotfire. Proven and advanced interaction with global partners What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way. In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards. Apply now for a career that defies imagination Objects in your future are closer than they appear. Join us. careers.amgen.com As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. . Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology. Amgen focuses on areas of high unmet medical need and leverages its biologics manufacturing expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential. For more information, visit www.amgen.com and follow us on www.twitter.com/amgen