Global Regulatory Product Planning Senior Manager – Obesity

Amgen Inc.

Job Overview

Location

United States - Remote

Job Type

Full-time

Full Job Description

📋 Description

• Serve as the global 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, 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.
• Lead cross-functional initiatives to achieve business objectives and drive organizational alignment within a complex, matrixed environment.
• Provide leadership visibility into emerging risks, resource considerations, and milestone readiness across a global regulatory landscape.
• Establish and refine planning processes and execution disciplines to enable regulatory excellence at scale within Amgen’s growing Obesity business.
• Present complex regulatory information, risks, and recommendations to senior leaders and governance bodies with clarity and strategic context.
• Translate complex regulatory and development interdependencies into actionable plans and recommendations that support product commercialization.
• Influence without direct authority to build productive relationships across regulatory and cross-functional teams.
• Manage multiple priorities in a fast-paced environment with strong organizational skills and attention to detail.
• Utilize planning, reporting, and visualization tools to communicate status, risks, dependencies, resource demands, and key performance indicators.

🎯 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
• Minimum of 2 years of experience directly managing people and/or leadership experience leading teams, projects, programs, or directing resource allocation
• Experience supporting global regulatory activities within obesity, cardiometabolic, or related therapeutic areas

🏖️ Benefits

• Comprehensive employee benefits package including Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
• Discretionary annual bonus program or sales-based incentive plan for field sales representatives
• Stock-based long-term incentives
• Award-winning time-off plans
• Flexible work models where possible
• Career development opportunities

Skills & Technologies

Senior

Remote

Degree Required

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Amgen Inc.

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About Amgen Inc.

Amgen Inc. is a global biotechnology company headquartered in Thousand Oaks, California. Founded in 1980, it discovers, develops, manufactures, and delivers human therapeutics targeting cancer, kidney disease, rheumatoid arthritis, bone disease, and other serious illnesses. Using advanced recombinant DNA and molecular biology techniques, Amgen produces biologic medicines such as Neulasta, Enbrel, and Prolia. The company operates R&D, manufacturing, and distribution facilities worldwide, investing heavily in genomic research to identify novel drug targets. Amgen also partners with academic institutions and smaller biotechs to expand its pipeline, aiming to transform breakthrough science into therapies that significantly improve patients’ lives.

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