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    Regulatory Affairs Senior Director - Washington DC, United States - Amgen

    Amgen
    Amgen Washington DC, United States

    3 weeks ago

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    Description
    It is key to our becoming one of the world's leading biotechnology companies. We are global collaborators who achieve together—researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. Regulatory Affairs Senior Director - Global Regulatory Leader - Oncology
    Amgen is seeking a Regulatory Affairs Senior Director supporting products in the Oncology Therapeutic Area.

    Global Regulatory Affairs (GRA) provides global regulatory leadership, expertise, and execution for the development, registration, and life cycle management of all Amgen molecules.

    In this vital, product-facing role you will lead one or more the Global Regulatory Teams (GRT) in the Regulatory Affairs organization.

    The purpose of the Global Regulatory Affairs Senior Director is:

    To independently develop a comprehensive regulatory strategy for one or more high complexity programs, typically in late-stage development and/or with multiple indications, 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
    To provide Regulatory leadership to cross-functional teams for high complexity programs with major Regulatory deliverables such as global original marketing applications
    Develop and execute global regulatory product strategies designed to achieve approval and target product labeling for prioritized assets in late development with highly complex development programs
    Represent GRA on the product team and other key commercialization governance bodies, guide and influence the organization to achieve Regulatory objectives
    Independently develop the Global Regulatory Strategic Plan and provide regulatory input into the product's Global Strategic Plan.

    Obtain input from the GRT members to develop a global regulatory strategy which supports product development, registration and lifecycle maintenance.

    Identify and communicate regulatory risks
    Provide 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
    Independently lead the planning and implementation of global regulatory filings (eg, clinical trial applications, marketing applications, label extensions)
    Ensure consistency of evidence-based global product communication (eg, regulatory submission documents)
    Monitor and assess impact of relevant global regulations, guidance, and current regulatory environment; Assess regulatory mechanisms to optimize product development (eg, expediting FIH studies, Orphan Drug Designation, Fast Track Designation, conditional /accelerated approval, compassionate use, and pediatric plan) and ensure appropriate incorporation into the global regulatory strategy
    Clearly and succinctly communicate regulatory strategies, associated risks, mitigations, and contingencies to the organization such that the probability of regulatory success and potential outcomes are well understood
    Lead GRTs and product teams in formal and informal communications with regulatory agencies
    Lead the approach and strategy for formal interactions with Regulatory agencies, especially those which could impact the global product strategy
    Represent Amgen Regulatory on external partnership teams at the product level
    Lead regulatory process improvements and initiatives
    Doctorate degree and 5 years of regulatory experience in biotech or science
    Master's degree and 8 years of regulatory experience in biotech or science
    Bachelor's degree and 10 years of regulatory experience in biotech or science
    Contemporary oncology experience desired
    Demonstrated ability to lead regulatory aspects of highly complex programs in late development
    Previous experience leading a Regulatory team for submission and approval of an original marketing application and/or major new indication supplemental application
    Ability to understand and communicate scientific/clinical information
    Planning and organizing abilities
    Able to prioritize and manage multiple activities
    Amgen offers a Total Rewards Plan 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 including:

    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 and bi-annual company-wide shutdowns
    Flexible work models, including remote work arrangements, where possible

    Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

    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.

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