Regulatory Affairs Senior Director - Global Regulatory Leader - Oncology

Job Title: Regulatory Affairs Senior Director - Global Regulatory Leader - Oncology Job Location: Washington D.C., District of Columbia, United States Job Location Type: Remote Job Contract Type: Full-time Job Seniority Level: 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. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions. 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 Director, Regulatory Affairs - Global Regulatory Leader – Oncology What you will do Let’s do this. Let’s change the world. Amgen is seeking a Senior Director, Regulatory Affairs supporting products in the Oncology Therapeutic Area. Global Regulatory Affairs (GRA) provides global regulatory leadership, expertise, and execution for the development, registration, and life cycle management of all Amgen molecules. In this vital, product-facing role you will lead one or more the Global Regulatory Teams (GRT) in the Regulatory Affairs organization. The purpose of the Global Regulatory Affairs Senior Director is: - To lead GRTs within Amgen’s GRAAS organization - To independently develop a comprehensive regulatory strategy for one or more high complexity programs, typically in late-stage development and/or with multiple indications, that takes into account worldwide regulatory requirements to drive product development, global registration, achievement and maintenance of desired regional labeling, and effective regulatory agency interactions - To provide Regulatory leadership to cross-functional teams for high complexity programs with major Regulatory deliverables such as global original marketing applications Key Responsibilities include: - Develop and execute global regulatory product strategies designed to achieve approval and target product labeling for prioritized assets in late development with highly complex development programs - Lead GRTs - Represent GRA on the product team and other key commercialization governance bodies, guide and influence the organization to achieve Regulatory objectives - Independently develop the Global Regulatory Strategic Plan and provide regulatory input into the product’s Global Strategic Plan. Obtain input from the GRT members to develop a global regulatory strategy which supports product development, registration and lifecycle maintenance. Identify and communicate regulatory risks - Provide regulatory direction in the development of the core data sheet to align commercial objectives in the context of available and expected scientific data, regulatory guidance, and precedent - Independently lead the planning and implementation of global regulatory filings (eg, clinical trial applications, marketing applications, label extensions) - Ensure consistency of evidence-based global product communication (eg, regulatory submission documents) - Monitor and assess impact of relevant global regulations, guidance, and current regulatory environment; advise product teams and GRT on implications of pertinent changes - Assess regulatory mechanisms to optimize p