Job Description

Career Category

Regulatory

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.

Regulatory Policy and Intelligence Senior Manager

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 support the development, articulation, and implementation 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:

• Promotes internal awareness of key regulatory policy activities, including International Council for Harmonization (ICH) activities; drives and coordinates alignment and implementation considerations across Amgen functions.

• Prepares presentations and other communications to support alignment on positions and strategies across Amgen functions and regions.

• Investigates policy research questions on key policy topics and determines the implications of emerging draft and final regulations and guidance documents.

• Analyzes regulatory guidances and other regulatory policy documents to inform positions and impact assessments.
• Supports global commenting process on health authority consultations with input from stakeholders.

• 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 or 2 years of regulatory experience
OR
Master’s degree and 4 years of related experience

OR
Bachelor’s degree and 6 years of regulatory experience
OR
Associate’s degree and 10 years of regulatory experience
OR
High school diploma / GED and 12 years of regulatory experience

Preferred Qualifications:

• Doctorate or Master’s degree (scientific area) and 6 years of directly related regulatory policy experience, including knowledge of FDA or EMA, or international regulators.
• Bachelor’s degree (scientific area) and 8 years of directly related experience
• In-depth regulatory experience in the U.S.

• In-depth knowledge of U.S. legislation and regulations relating to medicinal products.
• 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 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, 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 where possible. Refer to the Work Location Type in the job posting to see if this applies.

Apply now and make a lasting impact with the Amgen team.

careers.amgen.com

In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.

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.

Sponsorship

Sponsorship for this role is not guaranteed.

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

141,588.75USD -191,561.25 USD