Regulatory Affair Director - Global Regulatory Leader (Rare Disease)

Regulatory Affair Director – Global Regulatory Leader (Rare Disease) The Global Regulatory Leader (GRL) is a product‑facing role that leads the Global Regulatory Team within Amgen’s Global Regulatory Affairs department. The GRL develops and executes a comprehensive regulatory strategy that incorporates worldwide regulatory requirements to drive product development, global registration, market‑labeling, and regulatory agency interactions. The role also provides regulatory expertise and guidance to product teams, including Product Team (PT), Evidence Generation Team (EGT), and Global Safety Team (GST). Key Responsibilities Develop Global Regulatory Strategic Plan by integrating regional regulatory strategies and providing regulatory input into the Global Strategic Plan. Represent GRA on PT and EGT to ensure development of product registration strategies and plans aimed at regulatory approval and product labeling. Provide regulatory direction in the development of the core data sheet to align commercial objectives with scientific data, regulatory guidance, and precedent. Lead development, review, and approval of the Target Product Label (TPL). Obtain input from GRT members (e.g., RRLs, RA CMC, Safety) to develop a global regulatory strategy that supports product development, registration, and lifecycle maintenance. Plan and implement global regulatory filings (e.g., clinical trial applications, marketing applications, label extensions, CMC changes). Ensure consistency of evidence‑based global product communication in regulatory submission documents. Conduct contingency regulatory planning and risk assessment for global product development strategies and agency interactions. Monitor and assess the impact of relevant global regulations, guidances, and the current regulatory environment. Incorporate regulatory mechanisms that optimize product development (e.g., expediting FIH studies, Orphan Drug Designation, Breakthrough Therapy or PRIME designations, Fast Track, conditional/accelerated approval, compassionate use, and pediatric plan) into the global regulatory strategy. Communicate well‑defined, successful regulatory strategies throughout the organization, ensuring expectations are understood. Produce innovative alternative strategies that communicate associated risks. Consistently communicate Amgen’s position cross‑functionally and across all documents. Articulate and educate the likelihood of regulatory success based on proposed strategies. Accurately predict regulatory agency expectations and outcomes. Health Authority Interactions Direct global regulatory agency interaction strategies in collaboration with regional colleagues. Ensure effective regulatory agency communications by leading core regulatory and cross‑functional teams (e.g., GRTs, filing teams). Ensure consistent communication of product information to Health Authorities. Attend key regulatory agency meetings that could impact the global product strategy. Collaboration Lead GRT to develop and execute team goals. Provide coaching and mentoring to GRT members. Integrate regional regulatory representative input into GRT and regulatory plans. Communicate and ensure alignment of global functional and cross‑functional goals and objectives. Represent Global Regulatory Affairs on key commercialization teams (e.g., PT, EGT, GST). Represent Amgen GRA on external partnership teams at the PT level. Provide education and training on regulatory strategies and compliance issues to other PT functions. Ensure regulatory product compliance for product (e.g., IMR, PMCs, pediatric and other agency commitments). External Engagement Advocate for Amgen/GRAAS by building strong relationships with key external stakeholders, including senior regulatory agencies, trade associations, and influential professional bodies. Work externally to influence regulatory legislative environment in line with Amgen policy priorities for the therapeutic area. Participate in external review processes for commenting and policy activities as indicated by expertise. Develop regulatory due diligence assessment for licensing/acquisition opportunities, as assigned by management. Basic Qualifications Doctorate degree and 4 years of directly related experience. Master’s degree and 8 years of directly related experience. Bachelor’s degree and 10 years of directly related experience. At least 4 years of experience directly managing people and/or leading teams, projects, programs, or directing resource allocation. Preferred Qualifications Demonstrated ability to lead teams. Strong oral and written communication skills. Ability to understand and communicate scientific/clinical information. Understanding of regulatory activities and their impact on projects and processes. Ability to anticipate and mitigate future strategic issues and uncertainties. Conflict resolution and negotiation skills to develop beneficial outcomes. Cultural awareness and sensitivity to achieve results across regional, country, and international borders. Benefits 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. Discretionary annual bonus program. Stock‑based long‑term incentives. Award‑winning time‑off plans. Flexible work models where possible. Salary 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. Equal Opportunity Employment 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. #J-18808-Ljbffr Amgen Inc. (IR)