Regulatory Policy and Intelligence - US Director

Amgen • Thousand Oaks, CA

1d

About The Position

HOW MIGHT YOU DEFY IMAGINATION? If you feel like you’re part of something bigger, it’s because you are. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies. We are global collaborators who achieve together—researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. It’s time for a career you can be proud of. Regulatory Policy and Intelligence - US Director Live What you will do Let’s do this. Let’s change the world. Global Regulatory Policy team engages regulators, industry and professional associations, and patient advocates externally and subject matter experts across Amgen to advance important policy issues within the U.S. aligned with Amgen’s goals and priorities. In this vital role you will lead the development and articulation of Amgen's positions on regulatory policies that impact Amgen's business and will serve as a U.S. Policy Lead for Global Regulatory Policy and Intelligence.

Requirements

• Doctorate degree and 4 years of related experience
• Master’s degree and 7 years of related experience
• Bachelor’s degree and 9 years of related experience
• deep knowledge and understanding of the U.S. regulatory environment
• provide insights to internal stakeholders
• shape the external regulatory environment to support Amgen priorities

Responsibilities

• Masters a range of regulatory policy topics and provides strategic U.S> regulatory policy advice and guidance related to Amgen’s product portfolio , including a focus on artificial intelligence and emerging regulatory technologies (e.g., cloud-based submissions)
• Engages US regulatory authorities, industry, and professional associations at the policy level
• Leverages key relationships with FDA staff and industry and trade association colleagues to advance Amgen's position related to regulatory policy
• Coordinates the implementation of new U.S. regulatory policy and guidance across Amgen functions
• Engages cross-functional teams to develop strategic/long-term plans for the development and implementation of policies
• Masters a range of regulatory policy topics as assigned, including topics such as Chemistry, Manufacturing, and Controls (CMC), Precision Medicine, and Combination Products
• Leads the development and execution of strategic plans for each assigned policy area.
• Ensures that Amgen's regulatory policy positions are successfully represented to inform policy development and implementation
• Fosters a reputation with regulators as being science-based, reliable and trustworthy by advocating sound for policies
• Provides internal stakeholders (e.g., Global Government Affairs, R&D, Commercial, Legal) with a strategic regulatory policy perspective
• Assists and advises senior leadership in selecting issues, establishing priorities and developing and implementing regulatory policy advocacy plans
• Assists in creating the necessary infrastructure/processes for developing the regulatory policy and intelligence function

Benefits

• health and welfare plans for staff and eligible dependents
• financial plans with opportunities to save towards retirement or other goals
• work/life balance
• 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

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Education Level: Ph.D. or professional degree
• Number of Employees: 5,001-10,000 employees