Executive Director of Regulatory Affairs - Obesity and Related Conditions

Amgen • Thousand Oaks, CA

2d • $255,302 - $345,408

About The Position

Join Amgen’s Mission of Serving Patients At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do. Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity-related conditions. 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. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. Executive Director of Regulatory Affairs & Obesity Related Conditions What you will do Let’s do this. Let’s change the world. In this vital role as Executive Director of Regulatory Affairs, you will direct regulatory affairs activities within an assigned disease area, ensuring compliance with applicable laws and regulations. You will also provide strategic direction and leadership to the regulatory affairs team. The Executive Director of Regulatory Affairs is a product facing cross-indication regulatory integration role that leads a designated part of the Obesity and Related Conditions Global Regulatory Therapeutic Area in the Global Regulatory Affairs organization. This role ensures strategic coherence, alignment, and risk management across multiple products with concurrent indications and global filings. This role will report into the Vice President, Global Regulatory Affairs.

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
• 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

Nice To Haves

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

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

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.

What This Job Offers

• Job Type: Full-time
• Career Level: Executive
• Education Level: Ph.D. or professional degree