[Remote] Global Regulatory Product Planning Senior Manager – Obesity

Note: The job is a remote job and is open to candidates in USA. Amgen is a leading biotechnology company focused on serving patients living with serious illnesses. They are seeking a Global Regulatory Product Planning Senior Manager to lead regulatory planning for a key obesity asset, ensuring alignment and execution readiness across global regulatory activities. The role involves maintaining regulatory priorities, managing risks, and coordinating with cross-functional teams to support regulatory milestones.ResponsibilitiesServe as the regulatory product planning lead for a key obesity asset, maintaining an integrated view of regulatory priorities, milestones, dependencies, and risks across multiple indicationsDevelop and maintain a comprehensive Regulatory Product Plan that aligns regulatory objectives and activities, health authority interactions, development milestones, and major business prioritiesPartner with Global Regulatory Leads (GRLs), regional regulatory leads, and regulatory functional representatives to drive alignment on key deliverables, timelines, risks, and execution strategiesEstablish and maintain visibility into critical regulatory milestones, ensuring leadership has a clear understanding of readiness, risks, dependencies, and potential impacts to regulatory objectivesFacilitate regulatory planning forums to support decision-making, issue resolution, and proactive management of emerging regulatory challengesIdentify, assess, and proactively manage risks that could affect regulatory execution, working with stakeholders to develop and implement mitigation strategiesCoordinate regulatory readiness activities in support of key program milestones, major health authority interactions, and submission-related deliverablesDrive integration across indications, regulatory disciplines, regions, and cross-functional partners to ensure consistent planning and execution across the productPartner with the Global Filing Team, Regulatory Operations, and other stakeholders to ensure alignment between strategic regulatory priorities and operational execution plansSupport resource and workload planning discussions by providing insight into upcoming regulatory demands, key deliverables, and organizational capacity considerationsDevelop and maintain regulatory planning metrics, dashboards, and reporting tools that provide actionable insights to leadershipSkillsDoctorate degree and 2 years of directly related experienceMaster's degree and 6 years of directly related experienceBachelor's degree and 8 years of directly related experienceAssociate's degree and 10 years of directly related experienceHigh school diploma / GED and 12 years of directly related experienceMinimum of 2 years of experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation of resourcesExperience supporting global regulatory activities within obesity, cardiometabolic, or related therapeutic areasStrong understanding of global drug development and regulatory processes, including major regulatory milestones, health authority interactions, and submission requirements across key regionsDemonstrated understanding of end-to-end product development and commercialization processes and the interdependencies that influence regulatory executionExperience developing and maintaining integrated plans within complex, matrixed organizationsDemonstrated ability to coordinate and align activities across multiple indications, functions, regions, and stakeholdersExperience supporting regulatory governance, business planning, portfolio planning, or strategic program management activitiesExperience presenting complex information, risks, and recommendations to senior leaders and governance bodiesProven ability to identify, assess, and mitigate risks while balancing competing priorities and evolving business needsExperience driving organizational readiness for major regulatory milestones, health authority interactions, and business-critical deliverablesStrong strategic thinking and problem-solving skills with the ability to translate complex information into actionable plans and recommendationsDemonstrated ability to establish new processes, operating models, or planning frameworks within a rapidly evolving environmentDemonstrated ability to influence without direct authority and build productive relationships across regulatory and cross-functional teamsExcellent organizational skills with a proven ability to manage multiple priorities in a fast-paced environmentStrong written, verbal, and presentation skillsExperience utilizing planning, reporting, and visualization tools to communicate status, risks, dependencies, resource demands, and key performance indicatorsDemonstrated ability to lead cross-functional initiatives and drive organizational alignment to achieve business objectivesBenefitsA 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 accountsA discretionary annual bonus program, or for field sales representatives, a sales-based incentive planStock-based long-term incentivesAward-winning time-off plansFlexible work models where possible. Refer to the Work Location Type in the job posting to see if this applies.Company OverviewAmgen is a biotechnology company that develops and manufactures human therapeutics for various illnesses and diseases. It was founded in 1980, and is headquartered in Thousand Oaks, California, USA, with a workforce of 10001+ employees. Its website is http://www.amgen.com.Company H1B SponsorshipAmgen has a track record of offering H1B sponsorships, with 42 in 2026, 429 in 2025, 485 in 2024, 485 in 2023, 540 in 2022, 460 in 2021, 444 in 2020. Please note that this does not guarantee sponsorship for this specific role.