Regulatory Affair Director - Global Regulatory Leader (Rare Disease)

Regulatory Affair Director - Global Regulatory Leader (Rare Disease) What you will do Let’s do this. Let’s change the world. 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. Additionally, you will provide regulatory expertise and guidance to product teams (eg, Product Team (PT), Evidence Generation Team (EGT), Global Safety Team (GST)). Key Responsibilities:

STRATEGY AND EXECUTION

Develops Global Regulatory Strategic Plan through integration of regional regulatory strategies and provide regulatory input into the Global Strategic Plan. Represents GRA on PT and EGT to ensure development of product registration strategies and development plans aimed at achieving regulatory approval and product labeling. Provides regulatory direction in the development of the core data sheet to align commercial objectives in the context of available and expected scientific data, regulatory guidance and precedent. Leads development, review and approval of the target product label (TPL). Obtains input from the GRT members (e.g. RRLs, RA CMC, Safety, etc.) to develop a global regulatory strategy which supports product development, registration and lifecycle maintenance. Leads the planning and implementing global regulatory filings (e.g. clinical trial applications, marketing applications, label extensions, CMC changes). Ensures consistency of evidence-based global product communication (e.g. regulatory submission documents). Conducts contingency regulatory planning/risk assessment for global product development strategies and agency interactions. Monitors and assesses impact of relevant global regulations, guidances, and current regulatory environment. Ensures guidance on regulatory mechanisms to 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) are assessed and incorporated into the global regulatory strategy. Consistently communicates well defined, successful regulatory strategies throughout the organization such that expectation is understood. Produces strategies that provide innovative alternatives which communicate the associated risks. Communicates Amgen’s position consistently cross-functionally and across all documents. Develops the ability to articulate and educate the likelihood of regulatory success based on proposed strategies. Develops ability to accurately predict expectations and outcomes by regulatory agencies.

HEALTH AUTHORITY INTERACTIONS

Directs global regulatory agency interaction strategies, in collaboration with regional colleagues. Ensures effective regulatory agency communications by leading core regulatory and cross functional teams (e.g. GRTs, filing teams). Ensures consistent communication of product information to Health Authorities. Attends key regulatory agency meetings which could impact the global product strategy.

COLLABORATION

Leads GRT to develop and execute team goals. Provides coaching and mentoring to GRT members. Integrates regional regulatory representative input into GRT and regulatory plans. Communicates and ensures alignment of global functional and cross-functional goals and objectives. Represents Global Regulatory Affairs on key commercialization teams (e.g, PT, EGT, GST). Represents Amgen GRA on external partnership teams at the PT level. Provides education and training on regulatory strategies and compliance issues to other PT functions. Ensures regulatory product compliance for product (e.g. IMR, PMCs, pediatric and other agency commitments).

EXTERNAL

Under the leadership of the GRAAS Policy leaders: Advocates for Amgen/GRAAS by building strong relationships with key external stakeholders including senior regulatory agencies, trade associations, and influential professional bodies. Works 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 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 and 4 years of directly related experience OR Master’s degree and 8 years of directly related experience OR Bachelor’s 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 experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation or 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 against future strategic issues & 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 both regional country and International borders. What you can expect of 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. 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. #J-18808-Ljbffr Amgen SA