Global Regulatory Product Planning Senior Manager – Obesity

At Amgen if you feel like youre part of something bigger its because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do.

Since 1980 weve helped pioneer the world of biotech in our fight against the worlds toughest diseases. With our focus on four therapeutic areas Oncology Inflammation General Medicine and Rare Disease we reach millions of patients each year. As a member of the Amgen team youll help make a lasting impact on the lives of patients as we research manufacture and deliver innovative medicines to help people live longer fuller happier lives.

Our award-winning culture is collaborative innovative and science based. If you have a passion for challenges and the opportunities that lay within them youll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Global Regulatory Product Planning Senior Manager Obesity

Lets do this. Lets change the world. The Regulatory Science and Patient Safety organization is seeking a Global Regulatory Product Planning Senior Manager to support a key strategic asset within the Obesity and Related Conditions Therapeutic Area spanning multiple indications and global regulatory activities. This role serves as the integrated regulatory planning lead for the product driving alignment visibility and execution readiness across multiple indications and all global regulatory activities. The individual will be responsible for maintaining a comprehensive view of regulatory priorities milestones risks and dependencies to support predictable regulatory execution throughout the product lifecycle.

Operating within the Regulatory Business Performance Team this role partners closely with Global Regulatory Leads (GRLs) regional regulatory leads regulatory functional representatives and cross-functional stakeholders to ensure the organization is prepared to meet critical regulatory objectives. This position is responsible for integrating regulatory activities across indications functions and regions proactively identifying risks and driving organizational readiness for key regulatory milestones and decisions.

As a foundational role within Amgens growing Obesity business the Senior Manager will help establish planning processes and execution disciplines that enable regulatory excellence at scale. This individual will provide leadership visibility into emerging risks resource considerations and milestone readiness while fostering alignment across a complex and evolving global regulatory environment.

Key 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.

What we expect of you

We are all different yet we all use our unique contributions to serve patients. The dynamic professional we seek is a leader with these qualifications.

Basic Qualifications:

Doctorate degree and 2 years of directly related experience

OR

Masters degree and 6 years of directly related experience

OR

Bachelors degree and 8 years of directly related experience

OR

Associates degree and 10 years of directly related experience

OR

High school diploma / GED and 12 years of directly related experience

In addition to meeting at least one of the above requirements you must have a minimum of 2 years of experience directly managing people and/or leadership experience leading teams projects programs or directing the allocation or resources. Your managerial experience may run concurrently with the required technical experience referenced above

Preferred Qualifications:

• 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.

As we work to develop treatments that take care of others we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture well support your journey every step of the way.

The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to relevant skills experience and qualifications.

In addition to the base salary Amgen offers a Total Rewards Plan based on eligibility comprising of health and welfare plans for staff and eligible dependents financial plans with opportunities to save towards retirement or other goals work/life balance and career development opportunities that may include:

• 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.

In any materials you submit you may redact or remove age-identifying information such as age date of birth or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.

Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.

Sponsorship for this role is not guaranteed.

As an organization dedicated to improving the quality of life for people around the world Amgen fosters an inclusive environment of diverse ethical committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together we compete in the fight against serious disease.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race color religion sex sexual orientation gender identity national origin protected veteran status disability status or any other basis protected by applicable law.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process to perform essential job functions and to receive other benefits and privileges of employment. Please contact us to request accommodation.

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