Note: The job is a remote job and is open to candidates in USA. Amgen is a leading biotechnology company dedicated to serving patients living with serious illnesses. They are seeking a Global Regulatory Product Planning Senior Manager to support their Obesity and Related Conditions Therapeutic Area by leading regulatory planning and execution across multiple indications and global activities.
Responsibilities
- 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
Skills
- 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 of 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
- 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
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, and 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. Refer to the Work Location Type in the job posting to see if this applies.
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