Regulatory Policy and Intelligence Senior Manager

Regulatory Policy and Intelligence Senior Manager Join Amgen’s mission of serving patients and be part of a team that pioneers biotech solutions for serious illnesses. In this role you will support the development, articulation, and implementation of Amgen’s positions on regulatory policies that impact our business and report to the U.S. Lead for Global Regulatory Policy and Intelligence. What you will do The Global Regulatory Policy and Intelligence team advances policy issues aligned with Amgen’s goals by engaging with regulators, industry trade associations, and patient advocates, along with internal subject‑matter experts. In this crucial role you will: Promote internal awareness of key regulatory policy activities, including ICH developments, and drive alignment across Amgen functions. Prepare presentations and communications to support alignment on positions and strategies. Investigate policy research questions on key topics and assess implications of emerging regulations and guidance. Analyze regulatory guidance and policy documents to inform positions and conduct impact assessments. Support the global commenting process on health authority consultations. Plan and help manage projects for agreed policy objectives in partnership with policy leads and management. What we expect of you We seek a leader with strong analytical, communication, and teamwork skills who can work collaboratively across functional areas in a fast‑paced environment. Basic Qualifications Doctorate or 2 years of regulatory experience Masters degree and 4 years of related experience Bachelor’s degree and 6 years of regulatory experience Associate’s degree and 10 years of regulatory experience High school diploma/ GED and 12 years of regulatory experience Preferred Qualifications Doctorate or Masters in a scientific area with 6+ years of regulatory policy experience and knowledge of FDA, EMA, or international regulators. Bachelor’s in a scientific area with 8+ years of directly related experience. In‑depth regulatory experience in the U.S. Strong knowledge of U.S. legislation and regulations relating to medicinal products. Team player with a track record of cross‑functional collaboration. Excellent oral and written communication skills. Strong interpersonal, problem‑solving, and conflict‑resolution abilities. Demonstrated ability to work well with people at all levels, with a positive attitude, tact, and diplomacy. Attention to detail and high quality in a fast‑paced environment. Organizational, process, and project management skills. Computer skills with MS Office, Smartsheet, and SharePoint. Benefits Competitive salary and total rewards plan. Comprehensive health and welfare plans for staff and eligible dependents. Retirement and savings plans with generous company contributions. Discretionary annual bonus program and stock‑based long‑term incentives. Generous time‑off plans and flexible work models where possible. Amgen is an Equal Opportunity Employer. We consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, disability status, or any other basis protected by law. We will provide reasonable accommodation to individuals with disabilities to participate in the application and interview process and to perform essential job functions. #J-18808-Ljbffr