Senior Associate - Regulatory Affairs

Career CategoryRegulatoryJob DescriptionJoin Amgen’s Mission of Serving PatientsAt Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do.Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.Senior Associate - Regulatory Affairs What you will doLet’s do this. Let’s change the world. In this vital role you will assist in the creation and submission of regulatory documents and may be the regulatory lead for a program under the supervision of a more experienced regulatory lead.Assist U.S. Regulatory Lead to support regional regulatory activities. Provide and maintain IND/BLA documentation support (e.g. annual reports, amendments) in collaboration with U.S. Regulatory LeadCreate and maintain product regulatory history documents and appropriately archive all regulatory documents and agency communicationsReview regional component of the Global Regulatory Plan and provide input to operational deliverablesEnsure compliance with submissions to regulatory agenciesSupport U.S. Regulatory Lead in review of HA interaction activitiesCollaborate with CRO’s / partners to support site initiation, as applicableCoordinate collection of functional documents in support of regulatory applicationsAs appropriate participate in GRT to support execution of regulatory strategyCoordinate QC of regulatory documentation (e.g. briefing packages)Provide primary authorship to routine regulatory correspondence (e.g. annual reports, investigator packages)Prepare regulatory packages and cross-reference letters to support investigator initiated studiesApprove drug shipment for Amgen and Investigator Initiated StudiesComplete regulatory forms to support agency communicationsProvide regulatory support to Commercial, Medical and Clinical departments through crossfunctionalinteractions in brand and therapeutic area teamsSupport process improvement initiatives, standards development, and metricsDescriptionAssist in template development and maintenanceRespond to specific requests from and communicate relevant issues to GRTDevelop Regulatory Position with teamsActively support regulatory complianceSupport the development and execution of GRT goalsWhat we expect of youWe are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is a self-starter with these qualifications.Basic Qualifications:Master’s degreeOrBachelor’s degree and 2 years of Regulatory Affairs experienceOrAssociate’s degree and 6 years of Regulatory Affairs experienceOrHigh school diploma / GED and 8 years of Regulatory Affairs experiencePreferred Qualifications:Master’s degree in a biology, life science, health science curriculum, or regulatory sciencewith biology curriculumRegulated industry, science or clinical practice experienceTimeline managementStrong communication skills - oral and writtenOrganizational skillsAd hoc meeting supportAgendas, minutesWhat you can expect of usAs 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 accountsA discretionary annual bonus program, or for field sales representatives, a sales-based incentive planStock-based long-term incentive