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Amgen Logo Amgen · IT - Administration

Regulatory Affairs Senior Associate

United States Employment contract 83974.90 - 113613.10 USD / Year · Job Posted June 29, 2026
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Job Description

Join Amgen’s Mission of Serving Patients. At 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. 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.

Job Responsibility

  • 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

Requirements

  • Master's degree
  • or Bachelor's degree and 2 years of regulatory or pharmaceutical experience
  • or Associate's degree and 6 years of regulatory or pharmaceutical experience
  • or High school diploma / GED and 8 years of regulatory or pharmaceutical experience

What we offer

  • 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
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