Career Category RegulatoryJob DescriptionHOW MIGHT YOU DEFY IMAGINATION?At Amgen, every challenge is an opportunity. And every opportunity brings the potential to change lives. Our shared mission—to serve patients—has driven our status as one of the world’s preeminent biotechnology companies, reaching over 10 million patients worldwide. Leverage your high-level expertise to lead and forge partnerships that advance the biotechnical and biopharmaceutical science that can turn the tide of serious, life-interrupting illnesses.Vice President, Regulatory Affairs - ObesityLiveWhat you will doLet’s do this. Let’s change the world. In this vital Vice President role, you will improve patient lives through leadership of the Regulatory Affairs for the therapeutic area of Obesity and Obesity Related Conditions (ORCs). In this role, the Vice President will provide expertise for the development, registration, and lifecycle management of all our Obesity and ORC molecules. As well as strategic regulatory influence locally and globally in addition to the development of successful, expedient, and innovative regulatory strategies for development and approval of Amgen products.ResponsibilitiesDevelops the vision of the Regulatory Therapeutic Area for Obesity and Obesity Related Conditions (ORCs) and drives its execution, ensuring the globalization of strategy and processRepresents the Regulatory Affairs Therapeutic Area (TA) with Amgen executive leadership, governance bodies, regulatory agencies, and external partnersHas oversight of, and is accountable for, all aspects of Regulatory TA strategies, decisions, and implementation plansProvides timely input to Amgen executive leadership, review committees and other cross-functional product meetingsAdvocates for Regulatory Affairs by building strong relationships with key external stakeholders including regulatory agencies and influential professional bodies, and seeks to influence regulatory policy globallyProvides strategic vision to guide the development of new department and cross-functional processes including technology and compliance initiativesExchanges regulatory information with other Global Regulatory Affairs and Strategy (GRAAS) leaders on an ongoing basis (e.g., prior to relevant senior management review committees and governance boards)Prioritizes projects within the TA to meet Corporate and R&D prioritiesAccountable for defining and delivering against TA goals and objectives, aligned with corporate, R&D, and GRAAS goalsReviews and approves alignment of sub-functional goals in RAProvides managerial leadership and direction to functional heads to facilitate issue resolution and allowing for appropriate prioritization or resources to achieve goalsEnsures staff are compliant with Amgen corporate and departmental training and SOP reviewProvides coaching, mentoring, and development of staffRecruits and retains regulatory professionals and assist in the recruitment of talented GRAAS and AMGEN staffDevelops TA goals in alignment with department goalsEnvisions and builds an organization and processes that support future department, company, and industry changesResponsible for TA budget and headcountAccountable for disseminating and representing corporate and departmental information to staff and ensuring understanding and adherence to changesDevelops plans for staff created annually and reviewed quarterlyConducts regular functional governance meetingsResponsible for thorough staff and organizational development including effective Talent Management, Succession Planning and Maximizing Amgen Potential (MAP) ProcessResponsible for organizational management through ERP tools, expense report reviews, invoice approvals, timecard review and approval, overtime approval, vacation requests, etc.WinWhat we expect of youWe are all different, yet we all use our unique contributions to serve patients. The professional we seek is a leader with these qualifications.Basic QualificationsDoctorate degree & 8 years of regulatory affairs experience ORMaster’s degree & 10 years of regulatory affairs experience ORBachelor’s degree & 12 years of regulatory affairs experience AND8 years of direct managerial experience. Previous experience managing other managersPreferred QualificationsPhD with 8 years of industry experience and management experienceThey will also embody the Amgen leadership attributes which are:Inspire: Create a connected, inclusive, and inspiring work environment that empowers talent to thriveAccelerate: Enable speed that matches the urgency of patient needs by encouraging progress over perfectionIntegrate: Connect the dots to amplify the collective power of Amgen to drive results for patients, staff, and shareholdersAdapt: Lead through change by adapting to an ever-changing environment and defining a clear course of action to deliver resultsThriveWhat you can expect of usAs 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.The annual base salary range for this opportunity in the U.S. is $307,500 - $512,500.In addition to the base salary, 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 planStock-based long-term incentivesAward-winning time-off plans and bi-annual company-wide shutdownsFlexible work models, including remote work arrangements, where possibleAmgen’s Commitment to Our StaffAt Amgen, our mission is serving patients. Our staff are dedicated to pushing the boundaries of science to transform medicine and turn the tide on serious illnesses. Central to achieving this mission is our “people-first” philosophy.We recruit the best talent, build an environment that facilitates career growth, and provide staff with the opportunity to make significant contributions for patients and our business.We equip all our staff members to live well-rounded, healthy lives. Most recently, Amgen added benefits for transgender employees and continues to pride itself on industry-leading, family-friendly offerings for families of all compositions.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..Salary Range 387,860.00 USD - 450,000.00 USD
