Executive Director of Regulatory Affairs - Obesity and Related Conditions

Overview

Join Amgen’s Mission of Serving Patients. As a member of the Amgen team, you’ll 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.

Responsibilities

• Lead, coach, and mentor staff to develop a high-performing regulatory organization grounded in continuous learning, with a strong focus on talent development, leadership capability, and a succession planning culture.
• Build strong alignment across global and regional teams ensuring clarity of purpose, priorities and coordinated execution.
• Guide integrated cross-indication regulatory strategy across Obesity programs, ensuring alignment of development pathways, evidence generation, and global registration approaches.
• Provide strategic regulatory expertise and guidance to therapeutic area commercialization teams and other governance bodies.
• Act as a trusted strategic partner to Global Regulatory Leaders (GRLs) providing guidance on complex regulatory decisions, risk management, and long-term strategy.
• Conduct management review and approval of Global Regulatory Strategic Plans.
• Conduct review and approval of key documents for regulatory submissions.
• Anticipate and translate the evolving regulatory landscape within therapeutic area into forward looking regulatory strategies and opportunities.
• Work externally to influence regulatory legislative environment in line with Amgen policy priorities for the therapeutic area.
• Oversee and participate in licensing/acquisition due diligence and other activities in partnership with Amgen licensing groups.
• Communicate and ensure alignment of global functional and cross-functional goals and objectives.

Requirements

• Demonstrated experience leading complex, multi-indication regulatory strategy integration.
• Demonstrated ability to lead teams.
• Strong communication skills - both oral and written.
• Ability to understand and communicate scientific information.
• Comprehensive understanding of regulatory activities and how they affect projects and processes.
• Demonstrable ability to set organizational direction & champion change and continuous improvement.
• Proven ability to anticipate and mitigate against future strategic issues & uncertainties.
• Ability to resolve conflicts and develop a course of action leading to a beneficial outcome.
• Proven ability to drive enterprise-level alignment under high portfolio complexity.

Qualifications

• Doctorate degree & 6 years of regulatory affairs experience OR
• Master’s degree & 10 years of regulatory affairs experience OR
• Bachelor’s degree & 12 years of regulatory affairs experience AND
• 6 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources.

Preferred Qualifications

• Demonstrated leadership of regulatory strategy for programs in obesity, metabolic disorders, endocrinology, cardiovascular risk, or related therapeutic areas.

Benefits

• 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 and bi-annual company-wide shutdowns.
• Flexible work models where possible.

Pay

The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is $255,302 - $345,408. Actual salary will vary based on several factors including, but not limited to, relevant skills, experience, and qualifications.

Schedule

Flexible work models where possible.