Manager, United States Regulatory Strategy, General Medicine

Job description

Career CategoryRegulatoryJob DescriptionJoin 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. Manager, United States Regulatory Strategy, General Medicine What you will do Let’s do this. Let’s change the world. In this vital role you will. Amgen is seeking a United States Regulatory Lead (USRL) Manager supporting products in the General Medicine Therapeutic Area. Global Regulatory Affairs (GRA) provides global regulatory leadership, expertise, and execution for the development, registration, and lifecycle management of all Amgen molecules. In this product-facing role, you will develop and execute U.S./regional regulatory strategy and tactics under general supervision, represent the region on global teams, and lead U.S. regulatory execution to enable clinical trials and maintain commercial licenses in compliance with local laws, regulations, and Amgen standards—with a strong focus on regulatory compliance and patient safety. Purpose: Ensure Amgen acquires and maintains required U.S. licenses/authorizations to support clinical trials and maintain marketed products, while ensuring regulatory compliance with a focus on patient safety. Reporting line: Based in the assigned region with interaction primarily on the Global Regulatory Team (GRT); reports to Global Regulatory Lead (GRL). 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. Responsibilities Execute U.S. regulatory strategy and deliverables for assigned programs and represent the region on global teams. Plan and manage U.S. regulatory submissions (e.g., clinical trial and marketing applications) aligned with global filing plans and U.S. regulatory requirements. Implement product-related regulatory tactics and activity plans in accordance with U.S. legislation, regulations, and internal standards. Provide content guidance for key U.S. regulatory documents and meetings consistent with Global Regulatory strategy (e.g., briefing content, submission components). Support U.S. labeling development in collaboration with the Labeling Working Group (LWG), incorporating scientific data, guidance, and precedent; support U.S. labeling negotiation activities. Provide regulatory guidance on U.S. mechanisms and pathways to optimize development (e.g., expedited programs, orphan considerations, pediatric plans, compassionate use where applicable). Obtain and maintain clinical trial authorizations and marketing application approvals, including support for Responses to Questions (RTQs) and other agency feedback. Communicate regulatory strategy and expectations within the team (e.g., GRT, affiliates/stakeholders) and work with line management to assess likelihood of success, expectations, and risks. Ensure ongoing regulatory compliance for assigned products (e.g., IMR accuracy, PMCs/commitments, pediatric and other agency obligations); escalate issues proactively. Maintain and apply U.S. regulatory intelligence: monitor evolving legislation/guidance; research precedent and history; assess and communicate potential impact (including competitor labeling where relevant). Support Health Authority interactions by acting as an agency contact as appropriate, documenting outcomes, and contributing to risk/contingency planning consistent with global strategy. Partner with cross-functional teams to support alignment and execution, including U.S.-specific considerations for data use in product communications (as applicable). What we expect of youWe are all different, yet we all use our unique contributions to serve patients. The qualified professional we seek is a Regulatory Manger with these qualifications. Basic Qualifications: Doctorate degree OR Master’s degree and 2 years of directly related experience OR Bachelor’s degree and 4 years of directly related experience OR Associate’s degree and 8 years of directly related experience OR High school diploma / GED and 10 years of directly related experience. Preferred Qualifications: Regulatory submissions experience and experience interacting with regulatory agencies (FDA) Working knowledge of U.S. legislation/regulations relating to medicinal products and applicable regulatory principles Understanding of drug development and the U.S. registration pathway (e.g., marketing applications, post-approval changes, extensions/renewals) Experience supporting regulatory strategy for programs in general medicine, metabolic disorders, endocrinology, or related therapeutic areas. Foundational scientific understanding of cardiovascular and metabolic diseases Strong written and oral communication skills; ability to communicate scientific/clinical information clearly Ability to anticipate issues, evaluate risks, and contribute to practical contingency planning Ability to resolve conflicts, influence without authority, and drive alignment across teams Cultural awareness and ability to operate effectively across global/regional teams 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 where possible. Refer to the Work Location Type in the job posting to see if this applies. Apply now and make a lasting impact with the Amgen team.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 deadlineAmgen 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. SponsorshipSponsorship for this role is not guaranteed. 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 ot