Regulatory Policy and Intelligence US Director

Career Category

Job Description

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.

Regulatory Policy and Intelligence - US Director

Live

What you will do

Lets do this. Lets change the world. Global Regulatory Policy team 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 Amgens goals and this vital role you will lead the development and articulation of Amgens positions on regulatory policies that impact Amgens business and will serve as a U.S. Policy Lead for Global Regulatory Policy and Intelligence.

Key Responsibilities include:

• Masters a range of regulatory policy topics and provides strategic U.S> regulatory policy advice and guidance related to Amgens product portfolio including a focus on artificial intelligence and emerging regulatory technologies (e.g. cloud-based submissions)
• 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 Amgens 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 policy topics as assigned including topics such as Chemistry Manufacturing and Controls (CMC) Precision Medicine and Combination Products. Leads the development and execution of strategic plans for each assigned policy area.
• Ensures that Amgens regulatory 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

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

Masters degree and 7 years of related experience

Or

Bachelors 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 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:

• 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.

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