Global Regulatory Policy Manager

Join Amgens Mission of Serving Patients

At Amgen, if you feel like youre part of something bigger, its because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do.

Since 1980, weve helped pioneer the world of biotech in our fight against the worlds 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, youll 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, youll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Global Regulatory Policy and Intelligence Manager What you will do

Lets do this. Lets change the world. The Global Regulatory Policy and Intelligence team advances important policy issues, aligned with Amgens 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 support 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 Global Regulatory Policy and Intelligence.

Key Responsibilities :

• Promotes internal awareness of key regulatory policy activities and coordinates Global Regulatory Policy communications across Amgen functions
• Prepares presentations and other communications to support alignment on positions and strategies across the Amgen organizations and regions.
• Investigates policy research questions on key policy topics and determine the implications of emerging regulatory developments.
• Analyzes regulatory guidances and other regulatory policy documents to inform policy strategies and positions.
• Supports the development of Amgen regulatory policy positions and strategies.
• Partners with policy leads and subject matter experts to develop whitepapers, policy analysis documents, and advocacy materials on priority policy issues.
• Plans and help manages projects for agreed upon policy objectives under the direction of 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

Masters degree and 2 years of regulatory experience

Bachelors degree and 4 years of regulatory experience

Associates degree and 8 years of regulatory experience

High school diploma / GED and 10 years of regulatory experience

Preferred Qualifications :

Bachelors degree in biology, chemistry, or life sciences and 2 years of regulatory experience, including knowledge of FDA or EMA, or international regulators.

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

Strong oral and written communication skills.

Masters degree in regulatory affairs or life sciences and 2 years of regulatory experience, including knowledge of FDA or EMA, or international regulators.

Strong interpersonal, problem solving, and conflict resolution skills.

Demonstrated ability to work well with people at all levels of an organization in demanding situations with a positive attitude, tact, diplomacy, and respect.

Demonstrated ability to work in a fast-paced environment while retaining a high attention to detail and quality.

Excellent organizational, process and project management skills.

Strong computer skills including experience with MS Office, Smartsheet, and SharePoint.

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, well 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 :

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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.