#WeareBiotech
Global Regulatory Submission Planning Sr. Manager – Obesity
Location
United States
Posted
16 days ago
Salary
$142.6K - $192.9K / year
Seniority
Senior
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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