Global Regulatory Submission Planning Sr. Manager– Obesity
Amgen
3 days ago
Remote friendly (United States)
United States
Corporate Functions
Global Regulatory Product Planning Senior Manager – Obesity
What You Will Do
Serve as the integrated regulatory product planning lead for a key obesity asset across multiple indications and global regulatory activities, maintaining visibility into priorities, milestones, risks, and dependencies to enable predictable execution throughout the product lifecycle.
Key Responsibilities
- Maintain an integrated view of regulatory priorities, milestones, dependencies, and risks across multiple indications.
- Develop and maintain a Regulatory Product Plan aligning regulatory objectives/activities, health authority interactions, development milestones, and business priorities.
- Partner with Global Regulatory Leads, regional regulatory leads, and regulatory functional representatives to align deliverables, timelines, risks, and execution strategies.
- Establish visibility into regulatory milestone readiness (readiness, risks, dependencies, and impacts).
- Facilitate planning forums for decision-making and resolution of emerging regulatory challenges.
- Identify, assess, and mitigate regulatory execution risks with stakeholders.
- Coordinate regulatory readiness for program milestones, major health authority interactions, and submission-related deliverables.
- Drive integration across indications, regions, regulatory disciplines, and cross-functional partners; align with Global Filing Team and Regulatory Operations.
- Provide input to resource/workload planning and develop planning metrics/dashboards.
Basic Qualifications
- Doctorate + 2 years; OR Master’s + 6 years; OR Bachelor’s + 8 years; OR Associate’s + 10 years; OR HS/GED + 12 years directly related.
- Plus minimum 2 years managing people and/or leading teams/projects/programs or resource allocation.
Preferred Qualifications
- Obesity/cardiometabolic global regulatory experience; strong global drug development/regulatory process knowledge.
- End-to-end development/commercialization understanding; integrated planning in matrixed orgs.
- Coordinate alignment across indications/functions/regions; governance/business/portfolio/strategic program experience.
- Present to senior leaders; risk mitigation; drive readiness for major milestones.
- Build new processes/frameworks; influence without authority; strong organization and communication; use planning/reporting/visualization tools.
Benefits (Total Rewards Plan—eligibility-based)
- Retirement and Savings Plan; group medical/dental/vision; life/disability; flexible spending accounts.
- Discretionary annual bonus (or sales incentive for field sales); stock-based long-term incentives; time-off plans; flexible work models where possible.
Application Instructions
- Apply now via careers.amgen.com. No application deadline; applications continue until a sufficient number are received or a candidate is selected.
What You Will Do
Serve as the integrated regulatory product planning lead for a key obesity asset across multiple indications and global regulatory activities, maintaining visibility into priorities, milestones, risks, and dependencies to enable predictable execution throughout the product lifecycle.
Key Responsibilities
- Maintain an integrated view of regulatory priorities, milestones, dependencies, and risks across multiple indications.
- Develop and maintain a Regulatory Product Plan aligning regulatory objectives/activities, health authority interactions, development milestones, and business priorities.
- Partner with Global Regulatory Leads, regional regulatory leads, and regulatory functional representatives to align deliverables, timelines, risks, and execution strategies.
- Establish visibility into regulatory milestone readiness (readiness, risks, dependencies, and impacts).
- Facilitate planning forums for decision-making and resolution of emerging regulatory challenges.
- Identify, assess, and mitigate regulatory execution risks with stakeholders.
- Coordinate regulatory readiness for program milestones, major health authority interactions, and submission-related deliverables.
- Drive integration across indications, regions, regulatory disciplines, and cross-functional partners; align with Global Filing Team and Regulatory Operations.
- Provide input to resource/workload planning and develop planning metrics/dashboards.
Basic Qualifications
- Doctorate + 2 years; OR Master’s + 6 years; OR Bachelor’s + 8 years; OR Associate’s + 10 years; OR HS/GED + 12 years directly related.
- Plus minimum 2 years managing people and/or leading teams/projects/programs or resource allocation.
Preferred Qualifications
- Obesity/cardiometabolic global regulatory experience; strong global drug development/regulatory process knowledge.
- End-to-end development/commercialization understanding; integrated planning in matrixed orgs.
- Coordinate alignment across indications/functions/regions; governance/business/portfolio/strategic program experience.
- Present to senior leaders; risk mitigation; drive readiness for major milestones.
- Build new processes/frameworks; influence without authority; strong organization and communication; use planning/reporting/visualization tools.
Benefits (Total Rewards Plan—eligibility-based)
- Retirement and Savings Plan; group medical/dental/vision; life/disability; flexible spending accounts.
- Discretionary annual bonus (or sales incentive for field sales); stock-based long-term incentives; time-off plans; flexible work models where possible.
Application Instructions
- Apply now via careers.amgen.com. No application deadline; applications continue until a sufficient number are received or a candidate is selected.