**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. **Regulatory Affairs Manager- US Regulatory Lead** **What you will do** Let’s do this. Let’s change the world. In this vital role, you will support a variety of products from a US regulatory perspective. As a member of the Global Regulatory Team (GRT), you will achieve the desired labeling by developing and implementing regional regulatory strategies and leading agency interactions. **Responsibilities include:** + Ensure that Amgen acquires and maintains all the licenses in order to support clinical trials for investigational medicinal products as well as market commercially approved medicinal products. + Ensure regulatory compliance, with a focus on patient safety. + Provide management and leadership to one or more leads and/or support staff. + Implement the approved regional strategy for assigned programs. + Advise the GRT on niche and/or geographically specific considerations in developing strategy. + Ensure the regional needs are well defined and implemented in collaboration with relevant partners. + Plan and lead US regulatory submissions (e.g. clinical trial and marketing applications) for products within Amgen's portfolio in compliance with global filing plans and local regulatory requirements. + Implementation of product-related regulatory strategies, Regulatory Affairs processes, and activity planning. + Provide content guidance for US regulatory documents and meetings. + Provide regulatory guidance on US regulatory mechanisms to optimize product development (e.g. expediting FIH studies, Orphan Drug, Fast Track, compassionate use and pediatric plan). + Lead the development of the US product label by collaborating with the Labeling Working Group to define commercial objectives in the context of available and expected scientific data, regulatory guidance and precedent. + Support US label negotiation activities. + Development, and execution of region-specific regulatory product strategies, including precedence, risk management and contingency planning. + Support GRT on regulatory implications and requirements related to global clinical development plans and objectives + Acquire and maintain IND and Marketing Application approvals including Response to Questions (RTQs) + Communicate regulatory strategies within team (e.g. GRT, local affiliates). + Develop predictions for expectations and risks associated with outcomes by regulatory agencies. + Ensure regulatory product compliance for product (e.g. pediatric and other agency commitments). + Ensure alignment and support for GRT strategy decisions. + Partner with management and peers to ensure consistency in procedures and agency interactions. + Maintain an awareness of new and developing legislation, regulatory policy and technical Regulatory guidance relating to Amgen products. + Perform regulatory research to acquire histories, precedence and information pertinent to regional product advancement. **What we expect of you** We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is a leader with these qualifications. **Basic Qualifications:** Doctorate Degree **Or** Master's Degree and 2 years of regulatory experience **Or** Bachelor's Degree and 4 years of regulatory experience **Or** Associate's degree and 8 years of regulatory experience **Or** High school diploma/GED and 10 years of regulatory experience **Preferred Qualifications:** + Knowledgeable about regulatory principles, working with regulatory submissions, interacting with regulatory agencies, and internal partners + Awareness of the registration procedures in the region for MA, post-approval changes, extensions, and renewals + Knowledge of national legislation and regulations relating to medicinal products + Experience in a regional regulatory environment in a related product area and development stage + Clinical Development experience is a plus + Working with policies, procedures, and SOP’s + Knowledge of drug development Scientific / Technical Excellence + Superior communication skills with the ability to understand and communicate scientific/clinical information to a broad audience + Ability to resolve conflicts and develop a course of action leading to a beneficial outcome + Strong cultural awareness and sensitivity to the changing global environment, with the goal of achieving results across regional, country, and international borders **What you can expect from 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. The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications. In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include: + A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts + A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan + Stock-based long-term incentives + Award-winning time-off plans + Flexible work models, including remote and hybrid work arrangements, where possible **Apply now** **for a career that defies imagination** Objects in your future are closer than they appear. Join us. **careers.amgen.com** In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information. **Application deadline** Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position. 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 an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. 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.