Regulatory Policy and Intelligence Associate Director

Career Category

Regulatory

Job Description

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.

Regulatory Policy and Intelligence Associate Director

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

OR
Bachelor’s degree and 7 years of regulatory experience
OR
Associate’s degree and 12 years of regulatory experience
OR
High school diploma / GED and 14 years of regulatory experience

Preferred Qualifications:

• Doctorate or Master’s degree (scientific area) and 10 years of directly related regulatory policy experience, including FDA and international regulators.

• Bachelor’s degree (scientific area) and 12 years of directly related experience.

• In-depth knowledge and demonstrated policy leadership with U.S. legislation and regulations relating to medicinal products.

• Trade association or consortia experience.

• A strong team player with a demonstrated track record of working collaboratively across functional areas.

• Strong oral and written communication skills.

• Strong interpersonal, problem solving, and conflict resolution skills.

• Demonstrated capacity to work well with people at all levels of the organizing in demanding situations with a positive attitude, tact, diplomacy, and respect.

• Demonstrated ability to work in a fact-paced environment with retaining a high attention to detail and quality.

• Excellent organization, process, and project management skills.

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What you can expect of us

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, we’ll support your journey every step of the way.

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