Amgen logo
Amgen

#WeareBiotech

Global Regulatory Submission Planning Sr. Manager – Obesity

ComplianceComplianceFull TimeRemoteSeniorTeam 10,001+Since 1980H1B SponsorCompany SiteLinkedIn

Location

United States

Posted

16 days ago

Salary

$142.6K - $192.9K / year

Seniority

Senior

Postgraduate Degree2 yrs expEnglish

Job Description

Global Regulatory Submission Planning Sr. Manager – Obesity

Amgen

• 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.

Job Requirements

  • Doctorate degree and 2 years of directly related experience OR Master’s degree and 6 years of directly related experience OR Bachelor’s degree and 8 years of directly related experience OR Associate’s degree and 10 years of directly related experience OR High school diploma / GED and 12 years of directly related experience
  • a minimum of 2 years of experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation or resources.
  • 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.
  • Excellent organizational skills with a proven ability to manage multiple priorities in a fast-paced environment.

Benefits

  • 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
  • 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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