Job Information
Amgen Regulatory Policy and Intelligence - US Director in Washington D.C., District Of Columbia
HOW MIGHT YOU DEFY IMAGINATION?
If you feel like you’re part of something bigger, it’s because you are. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies. We are global collaborators who achieve together—researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. It’s time for a career you can be proud of.
Regulatory Policy and Intelligence - US Director
Live
What you will do
Let’s do this. Let’s 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 within the U.S. aligned with Amgen’s 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 serve as Amgen’s U.S. Lead for Regulatory Policy and Intelligence.
Key Responsibilities include:
Manages Amgen’s global regulatory policy commenting process and staff providing knowledge of FDA policy precedents and process to deliver influential commenting deliverables to advance Amgen’s policy positions
Engages US regulatory authorities, industry, and professional associations at the policy level
Leverages key relationships with FDA staff and industry and trade association colleagues to advance Amgen's position related to regulatory policy
Coordinates the implementation of new U.S. regulatory policy and guidance across Amgen functions
Engages cross-functional teams to develop strategic/long-term plans for the development and implementation of policies
Masters a range of regulatory and R&D policy topics as assigned. Leads the development and execution of strategic plans for each assigned policy area.
Ensures that Amgen's regulatory and R&D policy positions are successfully represented to inform policy development and implementation
Fosters a reputation with regulators as being science-based, reliable and trustworthy by advocating sound for policies
Provides internal stakeholders (e.g., Global Government Affairs, R&D, Commercial, Legal) with a strategic regulatory policy perspective
Assists and advises senior leadership in selecting issues, establishing priorities and developing and implementing regulatory policy advocacy plans
Assists in creating the necessary infrastructure/processes for developing the regulatory policy and intelligence function
Ensures direct and dotted line staff are compliant with required training and SOPs, and conducts annual review of staff training records for direct line reports
Win
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. regulatory environment and can provide insights to internal stakeholders, as well as shape the external regulatory environment to support Amgen priorities and has these qualifications
Basic Qualifications:
Doctorate degree and 4 years of related experience
Or
Master’s degree and 7 years of related experience
Or
Bachelor’s degree and 9 years of related experience
Thrive
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
Apply now
for a career that defies imagination
Objects in your future are closer than they appear. Join us.
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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.