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Regulatory Affairs Senior Director
4 months ago
HOW MIGHT YOU DEFY IMAGINATION?
If you feel like youre part of something bigger, its because you are. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies. We are global collaborators who achieve togetherresearching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. Its time for a career you can be proud of.Regulatory Affairs Senior Director - Global Regulatory Leader - OncologyLive
What you will do
Lets do this. Lets change the world. 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 lead GRTs within Amgens GRAAS organizationTo 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 interactionsTo provide Regulatory leadership to cross-functional teams for high complexity programs with major Regulatory deliverables such as global original marketing applicationsKey Responsibilities include: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 programsLead GRTsRepresent GRA on the product team and other key commercialization governance bodies, guide and influence the organization to achieve Regulatory objectivesIndependently develop the Global Regulatory Strategic Plan and provide regulatory input into the products 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 risksProvide 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 precedentIndependently 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; advise product teams and GRT on implications of pertinent changesAssess 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 strategyClearly 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 understoodLead GRTs and product teams in formal and informal communications with regulatory agenciesLead the approach and strategy for formal interactions with Regulatory agencies, especially those which could impact the global product strategyRepresent Amgen Regulatory on external partnership teams at the product levelLead regulatory process improvements and initiativesWinWhat 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 5 years of regulatory experience in biotech or scienceOr Masters degree and 8 years of regulatory experience in biotech or scienceOr Bachelors degree and 10 years of regulatory experience in biotech or science Preferred Qualifications:Contemporary oncology experience desiredDemonstrated ability to lead regulatory aspects of highly complex programs in late developmentPrevious experience leading a Regulatory team for submission and approval of an original marketing application and/or major new indication supplemental applicationAbility to lead and build effective teamsStrong communication skills - both oral and writtenAbility to understand and communicate scientific/clinical informationAbility to anticipate and mitigate against future strategic issues and uncertaintiesAbility to resolve conflicts and develop a course of actionCultural awareness and sensitivity to achieve global resultsPlanning and organizing abilitiesAble to prioritize and manage multiple activitiesAbility to make complex decisions and solve problemsAbility to deal with ambiguityOrganizational savvyNegotiation skillsThriveWhat 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. 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. 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 possibleApply nowfor a career that defies imagination Objects in your future are closer than they appear. Join us. 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.