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Amgen Logo Amgen · IT - Administration

Global Regulatory Submission Planning Sr. Manager

United States Employment contract 142579.00 - 192901.00 USD / Year · Job Posted June 03, 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

  • Serve as the regulatory product planning lead for a key obesity asset, maintaining an integrated view of regulatory priorities, milestones, dependencies, and risks across multiple indications
  • Develop and maintain a comprehensive Regulatory Product Plan that aligns regulatory objectives and activities, health authority interactions, development milestones, and major business priorities
  • Partner with Global Regulatory Leads (GRLs), regional regulatory leads, and regulatory functional representatives to drive alignment on key deliverables, timelines, risks, and execution strategies
  • Establish and maintain visibility into critical regulatory milestones, ensuring leadership has a clear understanding of readiness, risks, dependencies, and potential impacts to regulatory objectives
  • Facilitate regulatory planning forums to support decision-making, issue resolution, and proactive management of emerging regulatory challenges
  • Identify, assess, and proactively manage risks that could affect regulatory execution, working with stakeholders to develop and implement mitigation strategies
  • Coordinate regulatory readiness activities in support of key program milestones, major health authority interactions, and submission-related deliverables
  • Drive integration across indications, regulatory disciplines, regions, and cross-functional partners to ensure consistent planning and execution across the product
  • Partner with the Global Filing Team, Regulatory Operations, and other stakeholders to ensure alignment between strategic regulatory priorities and operational execution plans
  • Support resource and workload planning discussions by providing insight into upcoming regulatory demands, key deliverables, and organizational capacity considerations
  • Develop and maintain regulatory planning metrics, dashboards, and reporting tools that provide actionable insights to leadership

Requirements

  • Doctorate degree and 2 years of directly related experience
  • Master’s degree and 6 years of directly related experience
  • Bachelor’s degree and 8 years of directly related experience
  • Associate’s degree and 10 years of directly related experience
  • High school diploma / GED and 12 years of directly related experience
  • Minimum of 2 years of experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation or resources

Nice to have

  • Experience supporting global regulatory activities within obesity, cardiometabolic, or related therapeutic areas
  • Strong understanding of global drug development and regulatory processes, including major regulatory milestones, health authority interactions, and submission requirements across key regions
  • Demonstrated understanding of end-to-end product development and commercialization processes and the interdependencies that influence regulatory execution
  • Experience developing and maintaining integrated plans within complex, matrixed organizations
  • Demonstrated ability to coordinate and align activities across multiple indications, functions, regions, and stakeholders
  • Experience supporting regulatory governance, business planning, portfolio planning, or strategic program management activities
  • Experience presenting complex information, risks, and recommendations to senior leaders and governance bodies
  • Proven ability to identify, assess, and mitigate risks while balancing competing priorities and evolving business needs
  • Experience driving organizational readiness for major regulatory milestones, health authority interactions, and business-critical deliverables
  • Strong strategic thinking and problem-solving skills with the ability to translate complex information into actionable plans and recommendations
  • Demonstrated ability to establish new processes, operating models, or planning frameworks within a rapidly evolving environment
  • Demonstrated ability to influence without direct authority and build productive relationships across regulatory and cross-functional teams
  • Excellent organizational skills with a proven ability to manage multiple priorities in a fast-paced environment
  • Strong written, verbal, and presentation skills
  • Experience utilizing planning, reporting, and visualization tools to communicate status, risks, dependencies, resource demands, and key performance indicators
  • Demonstrated ability to lead cross-functional initiatives and drive organizational alignment to achieve business objectives

What we offer

  • Health and welfare plans for staff and eligible dependents
  • Financial plans with opportunities to save towards retirement or other goals
  • Work/life balance
  • Career development opportunities
  • Retirement and Savings Plan with generous company contributions
  • Group medical, dental and vision coverage
  • Life and disability insurance
  • Flexible spending accounts
  • Discretionary annual bonus program
  • Stock-based long-term incentives
  • Award-winning time-off plans
  • Flexible work models
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