Regulatory Policy and Intelligence Associate Director

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 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.

What you will do

Let’s do this. Let’s change the world. The Regulatory Policy and Intelligence team advances important policy issues, aligned with Amgen’s goals and priorities, by engaging externally with regulators, industry trade associations, consortia and other stakeholders, along with internal subject matter experts across Amgen. In this vital role, you will lead the development and articulation of Amgen's positions on regulatory policies that impact Amgen's business within a defined portfolio, exercising independent judgement and driving cross-functional alignment. You will report to the Amgen’s U.S. Lead for Regulatory Policy and Intelligence.

Primary Responsibilities

Foster U.S. trade association relationships and provide stewardship over the company’s regulatory and R&D-related trade association engagements.

Staff company executives in leadership roles in domestic and international forums.

Develop and lead enterprise-wide regulatory reform initiatives; implement strategies to shape policy outcomes, the external environment and identify related internal business needs for implementation.

Lead assigned policy initiatives from analysis and position development through external engagement and implementation, in partnership with policy leads and management.

Additional Responsibilities

Partner with policy leads and subject matter experts, including Government Affairs, R&D, Operations, and other relevant stakeholders, to develop advocacy materials on priority policy issues.

Prepare presentations and other communications to support alignment on positions and strategies across the Amgen organizations and regions.

Investigate policy research questions on key policy topics and determine the implications of emerging regulatory developments.

Analyze regulatory guidances and other regulatory policy documents to inform positions and impact assessments.

Plan and help manage projects for agreed upon policy objectives under the direction of and in partnership with policy lead(s) and management.

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 or 3 years of regulatory experience

OR

Master’s degree and 5 years of related experience