Global Regulatory Policy and Intelligence Director

Career Category

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. 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.

Global Regulatory Policy and Intelligence Director

What you will do

Let’s do this. Let’s change the world. The Global Regulatory Policy and Intelligence team advances important policy issues, aligned with Amgen’s goals and priorities, by engaging externally with regulators, industry trade associations, and patient advocates, 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 and will report to the Amgen’s U.S. Lead for Global Regulatory Policy and Intelligence.

Key Responsibilities:

• Masters a range of regulatory policy topics and provides strategic regulatory policy advice and guidance related to Amgen’s product portfolio, including a focus on real world data/evidence (RWD/RWE) and innovative clinical trials
• Monitors, analyzes, and anticipates changes in the regulatory environment, including their impact to Amgen’s policy strategy
• Develops and successfully advances Amgen's regulatory, safety, and R&D policy positions
• Assists and advises executive leadership on regulatory policy issues, including establishing priorities, and develops and executes regulatory policy advocacy plans
• Engages with US regulatory authorities, industry, and professional association leaders at the policy level; leverages understanding of regulatory health authorities, industry trade associations, and other relevant organizations, to advance Amgen's position related to regulatory policy
• Cultivates internal cross-functional partnerships and provides partners (e.g., Global Regulatory Affairs, Global Government Affairs, R&D, Medical, Safety, Legal) with a strategic regulatory policy perspective
• Promotes internal awareness of key regulatory policy changes and coordinates the implementation of new U.S. regulatory policy and guidance across Amgen functions

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 and 4 years of related experience in Pharmaceutical /Biotech industry or Health Agency with Regulatory/Policy or Legal experience

Or

Master’s degree and 7 years of related experience in Pharmaceutical /Biotech industry or Health Agency with Regulatory/Policy or Legal experience

Or

Bachelor’s degree and 9 years of related experience in Pharmaceutical /Biotech industry or Health Agency with Regulatory/Policy or Legal experience

Preferred Qualifications:

• Experience in regulatory policy development with comprehensive knowledge of biopharmaceutical industry
• Experience in building relationships with key stakeholders (e.g., trade associations, biopharmaceutical companies, FDA, etc.)
• Knowledge and use of regulatory intelligence tools to monitor, analyze, and anticipate changes in the regulatory environment
• Strong presentation and interpersonal communication skills
• Proven strategic and analytical abilities

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.

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

In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and 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, including remote and hybrid work arrangements, where possible

Apply now

for a career that defies imagination

Objects in your future are closer than they appear. Join us.

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Application deadline

Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Salary Range