Regulatory Policy and Intelligence Director

HOW MIGHT YOU DEFY IMAGINATION?

If you feel like youre part of something bigger, its because you are. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies. We are global collaborators who achieve togetherresearching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. Its time for a career you can be proud of.

What you will do

Lets do this. Lets change the world. Global Regulatory and R&D Policy engages regulators, industry and professional associations, and patient advocates externally and subject matter experts across Amgen to advance important policy issues aligned with Amgens 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 report to the Amgens U.S. Lead for Regulatory Policy and Intelligence.

• Masters a range of regulatory and R&D policy topics as assigned and provides strategic regulatory and R&D policy advice and guidance on a range of issues related to Amgens product portfolio
• Monitors, analyzes, and anticipates changes in the regulatory environment, including their impact to Amgens policy strategy
• Leads and/or participates in developing and successfully advancing Amgen's regulatory and R&D policy positions
• Assists and advises executive leadership on regulatory and R&D policy issues, including establishing priorities, and develops and executes Regulatory Policy strategy policy plans
• Engages with US regulatory authorities, industry, and professional association leaders at the policy level; leverages understanding of regulatory health authorities (e.g. FDA, EMA), 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 Government Affairs, R&D, Commercial, 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 Regulatory Policy and Intelligence professional we seek has a deep knowledge and understanding of the U.S. and global regulatory environment and can shape the external regulatory environment to support Amgen priorities and has these qualifications:

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

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

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

• Experience in building relationships with key stakeholders (e.g., trade associations, biopharmaceutical companies, FDA, EMA, other national competent authorities)
• Knowledge and use of regulatory intelligence tools to monitor, analyze, and anticipate changes in the regulatory environment
• Proven strategic and analytical abilities
• Knowledge of regulatory, R&D, safety, and drug development issues
• Experience in policy development
• Strong presentation and interpersonal communication skills
• Comprehensive knowledge of the biopharmaceutical industry, including development and execution of Regulatory Policy strategic plans

What you can expect of us

As we work to develop treatments that take care of others, we also work to care for our teammates professional and personal growth and well-being.

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.

Amgen offers a Total Rewards Plan comprising 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 including:

• 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, including remote work arrangements, where possible

for a career that defies imagination

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

Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

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.