Regulatory Affairs Senior Associate

Regulatory Affairs Senior Associate What you will do 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. Responsibilities: Assist US Regulatory Lead (USRL) to support US regulatory activities (e.g., development and submission of Investigational New Drug [IND] applications, Biologic License Applications [BLAs] and New Drug Applications [NDAs]; advisory committee meeting preparations) Provide and maintain IND/BLA/NDA documentation support (e.g., annual reports, amendments) in collaboration with USRL Create and maintain product regulatory history documents in the regulatory document management system and appropriately archive all regulatory documents and agency communications Review US component of the Global Regulatory Strategic Plan (GRSP) and provide input to operational deliverables; perform regulatory research to support the development of content for the GRSP plan as delegated by the Global or US Regulatory Lead Actively support regulatory compliance and ensure compliance of submissions to the US FDA Assist the Global or US Regulatory Lead by preparing supportive documentation for regulatory deliverables, including for example regulatory landscapes or research for the regulatory strategy and/or target product label. Coordinate collection of functional documents in support of regulatory applications Participate on Global Regulatory Teams (GRT) and assist Global Regulatory Leads with GRT meeting management (eg, agendas and meeting minutes) Assist the USRL in managing the process for responding to FDA questions Coordinate Quality Check (QC) of regulatory documentation (e.g., briefing packages) Provide primary authorship to routine regulatory correspondence (e.g., annual reports) Prepare regulatory packages and cross‑reference letters to support investigator‑initiated studies Complete regulatory forms to support agency communications (e.g., FDA form 1571) Support process improvement initiatives, standards development, and metrics Assist in template development and maintenance Respond to specific requests from and communicate relevant issues to GRT Support the development and execution of GRT goals 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 go‑getter with these qualifications. Basic Qualifications: Master’s degree Bachelor’s degree and 2 years of regulatory or pharmaceutical experience Associate’s degree and 6 years of regulatory or pharmaceutical experience High school diploma / GED and 8 years of regulatory or pharmaceutical experience What you can expect of us 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 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 Flexible work models where possible. Refer to the Work Location Type in the job posting to see if this applies. Equal Opportunity Employer Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. 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. #J-18808-Ljbffr Amgen SA