Regulatory Affair Director - Global Regulatory Leader (Rare Disease)

Join Amgen's mission of serving patients. 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. Regulatory Affair Director - Global Regulatory Leader (Rare Disease) What you will do The Global Regulatory Leader (GRL) is a product‑facing role that leads the Global Regulatory Team in the Regulatory Affairs organization. In this vital role, you will lead one or more Global Regulatory Teams within Amgen’s Global Regulatory Affairs department and develop a comprehensive regulatory strategy 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. You will also provide regulatory expertise and guidance to product teams (e.g., Product Team, Evidence Generation Team, Global Safety Team). Key Responsibilities Strategy and Execution Develop global regulatory strategic plan through integration of regional regulatory strategies and provide regulatory input into the Global Strategic Plan Represent GRA on Product Team and Evidence Generation Team to ensure development of product registration strategies and development plans aimed at achieving regulatory approval and product labeling Provide regulatory direction in the development of the core data sheet to align commercial objectives with available and expected 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 which supports product development, registration, and lifecycle maintenance Lead the planning and implementation of global regulatory filings (clinical trial applications, marketing applications, label extensions, CMC changes) Ensure consistency of evidence‑based global product communication (regulatory submission documents) Conduct contingency regulatory planning and risk assessment for global product development strategies and agency interactions Monitor and assess impact of relevant global regulations, guidances, and current regulatory environment Ensure guidance on regulatory mechanisms to optimize product development (e.g., expedite first‑in‑human studies, Orphan Drug Designation, Breakthrough Therapy, PRIME designation, Fast Track, conditional or accelerated approval, compassionate use, and pediatric plan) are assessed and incorporated into the global regulatory strategy Consistently communicate well‑defined, successful regulatory strategies throughout the organization such that expectations are understood Produce strategies that provide innovative alternatives and communicate associated risks Consistently communicate Amgen’s position cross‑functionally and across all documents Develop the ability to articulate and educate the likelihood of regulatory success based on proposed strategies Develop ability to accurately predict expectations and outcomes by regulatory agencies 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., Product Team, Evidence Generation Team, Global Safety Team) Represent Amgen GRA on external partnership teams at the Product Team level Provide education and training on regulatory strategies and compliance issues to other Product Team functions Ensure regulatory product compliance for product (e.g., IMR, PMCs, pediatric and other agency commitments) External Under the leadership of the GRAAS Policy leaders 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 May participate in external review process for commenting based on expertise May participate in external policy activities as indicated by expertise As assigned by management, develop regulatory due diligence assessment of licensing/acquisition opportunities What we expect of you Basic qualifications Doctorate degree and 4 years of directly related experience OR Masters degree and 8 years of directly related experience OR Bachelors degree and 10 years of directly related experience In addition to meeting at least one of the above requirements, you must have at least 4 years of experience directly managing people and/or leadership experience leading teams, projects, programs, or directing allocation of resources. Your managerial experience may run concurrently with the required technical experience referenced above. Preferred Qualifications Demonstrated ability to lead teams Strong communication skills – both oral and written Ability to understand and communicate scientific/clinical information Understanding of regulatory activities and how they affect projects and processes Ability to anticipate and mitigate future strategic issues and uncertainties Ability to resolve conflicts and develop a course of action leading to a beneficial outcome, influencing and negotiation skills Cultural awareness and sensitivity to achieve results across regional country and international borders What you can expect of us We support your professional and personal growth and well‑being. From competitive benefits to collaborative culture, we well 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 base salary, Amgen offers a total rewards plan, based on eligibility, comprising 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. The benefits 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 deadline: Amgen anticipates accepting applications until 6/25/26; however, we may continue accepting applications beyond this date if we do not receive a sufficient number of candidates. Sponsorship: Sponsorship for this role is not guaranteed. 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. As an Equal Opportunity employer, we 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 BioSpace