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Global Regulatory Policy Manager (US-REMOTE)

Employer
Amgen
Location
Los Angeles, CA
Start date
Oct 4, 2022

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Job Details

HOW MIGHT YOU DEFY IMAGINATION?

Youve earned your degree. How will you use that achievement to reach your goals? Do more with the knowledge youve worked hard to acquire and the passion you already have. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies, reaching over 10 million patients worldwide. Become the professional you are meant to be in this meaningful role.

Global Regulatory Policy ManagerLive

What you will do

Lets do this. Lets change the world. The Amgen Global Regulatory and Research and Development (GRR&D) Policy team is looking for an experienced Regulatory Policy Manager. GRR&D Policy is responsible for engaging regulators, industry and professional associations, and patient advocates externally to advance important policy issues aligned with Amgens goals and priorities. Our team is the Amgen lead on global regulatory policy issues and health authority engagement. We partner with business and other cross-functional organizations to develop Amgen regulatory policy positions and strategies to promote and support innovative, efficient, and effective approaches to developing and providing important new therapies to patients.

In this vital role you will contribute to the development and execution of Amgens positions on regulatory and R&D policies of global and regional importance that impact Amgens business. In this role you will support policy leads in the U.S., EU, and JAPAC. You will investigate policy research questions and conduct analyses, contribute to internal cross-functional teams, coordinate tasks with team members and across organizations, and support external engagement.

Responsibilities:
  • 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 policy strategies and positions.
  • Support the development of Amgen regulatory policy positions and strategies.
  • Prepare presentations and other communications to support alignment on positions and strategies across the Amgen organizations and regions.
  • Support external engagement with industry partners and regulators.
  • Partner with policy leads to develop whitepapers, policy analysis documents, and advocacy materials on priority policy issues.
  • Plan and help manage projects for agreed upon policy objectives under the direction of in partnership with policy lead(s).
Win

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 an individual with these qualifications.

Basic Qualifications:

Doctorate degree in biology, chemistry, or life science

OR

Masters degree in biology, chemistry, or life science and 3 years of regulatory experience, including knowledge of FDA or EMA, or other international biopharma regulatory policy.

Or

Bachelors degree in biology, chemistry, or life science and 5 years of regulatory experience, including knowledge of FDA or EMA, or other international biopharma regulatory policy.

Or

Associates degree and 10 years of regulatory experience, including knowledge of FDA or EMA, or other international biopharma regulatory policy.

Or

High school diploma / GED and 12 years of regulatory experience, including knowledge of FDA or EMA, or other international biopharma regulatory policy.

And

Previous managerial experience directly managing people and/or experience leading teams, projects, programs or directing the allocation of resources

Preferred Qualifications:

  • Masters degree in regulatory affairs or life sciences.
  • 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.
Thrive

Some of the vast rewards of working here

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.

  • Full support and career-development resources to expand your skills, enhance your expertise, and maximize your potential along your career journey
  • A diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
  • Generous Total Rewards Plancomprising health, finance and wealth, work/life balance, and career benefitswith compensation and benefits rated above 4 stars (out of 5) on Glassdoor
Apply now

for a career that defies imagination

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

careers.amgen.com
Join Us

If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.

Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.

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 but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.

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, 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.

Amgen requires all staff in the United States, Puerto Rico and Canada to be vaccinated from COVID 19 as a condition of employment. In accordance with applicable law, Amgen will provide reasonable accommodations to staff members who qualify on the basis of a medical reason or a sincerely held religious belief, practice, or observance. Such accommodation may not pose an undue hardship to Amgen, its operations, or its staff.

Company

We are all different, yet we have this in common: our mission to serve patients. This sense of shared purpose is key to our becoming one of the world’s leading biotechnology companies. It guides us as we continue to launch new medicines and reach millions of patients worldwide.

We live the mission.

We win together.

We thrive on continual challenge.

Our team of 22,000+ scientists and professionals worldwide bring distinct perspectives and experiences to all we do. We leverage our global talent to achieve together—to research, manufacture and deliver ever-better products and greater depth to our mission.

At Amgen, there is a strong correlation between our high level of diversity and performance. Because addressing issues with a wider range of perspectives and approaches leads to more creative problem-solving. Together, we’re transforming the promise of science and biotechnology into therapies that have the power to restore health.

Connect with us to explore how you can Win, Live, and Thrive at Amgen.

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Find Us
Website
Phone
805-447-1000
Location
Corporate Headquarters
One Amgen Center Drive
Thousand Oaks
California
91320-1799
United States
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