Global Regulatory Submission Planning Sr. Manager – Obesity

Amgen

Global Regulatory Product Planning Senior Manager at Amgen overseeing regulatory strategies for obesity therapies. Collaborating on global regulatory activities and ensuring successful product milestones.

Posted 6/3/2026full-timeRemote • 🇺🇸 United StatesSenior💰 $142,579 - $192,901 per yearWebsite

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

regulatory product planningregulatory objectiveshealth authority interactionsregulatory milestonesglobal drug developmentsubmission requirementsproduct developmentcommercialization processesintegrated plansmatrixed organizations

Soft Skills

leadershipteam managementproject managementorganizational skillsdecision-makingissue resolutionproactive managementcoordinationalignmentmulti-tasking

Certifications & Qualifications

Doctorate degreeMaster’s degreeBachelor’s degreeAssociate’s degreeHigh school diploma / GED

Industry Keywords

obesitycardiometabolictherapeutic areasregulatory activitiesglobal regulatory leadsstakeholdersdependenciesrisksexecution strategiesregulatory challenges

About the role

Key responsibilities & impact

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.

Requirements

What you’ll need

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

Comp & perks

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.