HOW MIGHT YOU DEFY IMAGINATION?

　　If you feel like you’re part of something bigger, it’s because you are. At Amgen, our shared mission—to serve patients—drives all that we do. 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. It’s time for a career you can be proud of.

　　Regulatory Affairs Director - Global Regulatory Leader (General Medicine/Metabolic)

　　Live

　　What you will do

　　Let’s do this. Let’s change the world. Amgen is seeking a Regulatory Affairs Director supporting products in the General Medicine – Metabolic 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 the Global Regulatory Team (GRT) in the Regulatory Affairs organization. The role of the Regulatory Affairs Director is to:

　　Lead GRTs within Amgen’s GRAAS organization,

　　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, and

　　Provide regulatory expertise and guidance to product teams.

　　Key Responsibilities:

　　Develop and execute the global regulatory product strategy

　　Lead GRTs

　　Represent Regulatory on the product team and other key commercialization governance bodies

　　Develop 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

　　Represent GRA on the product team

　　Develop registration strategies and plans aimed at achieving regulatory approval and product labeling

　　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

　　Lead the planning and implementation of global regulatory filings (e.g. clinical trial applications, marketing applications, label extensions, CMC changes)

　　Ensure consistency of evidence-based global product communication (e.g. regulatory submission documents)

　　Monitor and assess impact of relevant global regulations, guidance, and current regulatory environment

　　Ensure guidance on regulatory mechanisms to optimize product development (e.g. expediting FIH studies, Orphan Drug, Fast Track, conditional /accelerated approval, compassionate use and pediatric plan) is assessed and incorporated into the global regulatory strategy

　　Communicate consistently well defined, successful regulatory strategies throughout the organization such that expectation is understood

　　Ensure effective regulatory agency communications by leading core regulatory and cross functional teams (e.g. GRTs, filing teams)

　　Attend key regulatory agency meetings which could impact the global product strategy

　　Represent Amgen Regulatory on external partnership teams at the product level

　　Win

　　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 regulatory experience in biotech or science

　　Or

　　Master’s degree and 8 years of regulatory experience in biotech or science

　　Or

　　Bachelor’s degree and 10 years of regulatory experience in biotech or science

　　In addition to meeting at least one of the above requirements, you must have a minimum of 4 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation of resources. Your managerial experience may run concurrently with the required technical experience referenced above.

　　Preferred Qualifications:

　　Ability to lead and build effective teams

　　Strong communication skills - both oral and written

　　Ability to understand and communicate scientific/clinical information

　　Ability to anticipate and mitigate against future strategic issues & uncertainties

　　Ability to resolve conflicts and develop a course of action

　　Cultural awareness and sensitivity to achieve global results

　　Planning and organizing abilities

　　Able to prioritize and manage multiple activities

　　Ability to make complex decisions and solve problems

　　Ability to deal with ambiguity

　　Negotiation skills

　　Thrive

　　What you can expect of us

　　As we work to develop treatments that take care of others, we also work to care for our teammates’ professional and personal growth and well-being.

　　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

　　Apply now

　　for a career that defies imagination

　　Objects in your future are closer than they appear. Join us.

　　careers.amgen.com

　　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. Please contact us to request accommodation.