Regulatory Policy and Intelligence - US Director

BioSpace; Washington (District of Columbia); On-site; USD 120,000 - 150,000; Full time

Benefits offered by this job

Comprehensive employee benefits package

Discretionary annual bonus program

Stock-based long-term incentives

Award-winning time-off plans

Flexible work models

Job summary

A leading biotechnology company is seeking a US Director for Regulatory Policy and Intelligence. This role demands a deep knowledge of U.S. regulatory policies, and the ability to lead the development of strategic plans. The successful candidate will engage with regulatory authorities and industry stakeholders, advising senior leadership on policy issues and coordinating implementation across functions. A competitive benefits package and flexible work models will be part of the offering.

Qualifications

• Ability to engage with regulatory authorities and industry stakeholders.
• Experience in developing regulatory policies that impact business.
• Strong leadership skills to coordinate cross-functional teams.

Responsibilities

• Lead the policy development for regulatory issues affecting Amgen.
• Advise senior leadership on regulatory advocacy plans.
• Coordinate implementation of U.S. regulatory policy across functions.

Skills

Deep understanding of U.S. regulatory environment

Regulatory policy development

Strategic planning

Relationship management with FDA and industry

Education

Doctorate degree (4 years experience)

Masters degree (7 years experience)

Bachelor’s degree (9 years experience)

Job description

Regulatory Policy and Intelligence - US Director

Apply to the Regulatory Policy and Intelligence – US Director role at BioSpace.
Posted 4 days ago – be among the first 25 applicants.

What You Will Do

The 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 in 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 the U.S. Policy Lead for Global Regulatory Policy and Intelligence.

• Master a range of regulatory policy topics and provide strategic U.S. regulatory policy advice and guidance related to Amgen’s product portfolio, including a focus on artificial intelligence and emerging regulatory technologies (e.g., cloud‑based submissions).
• Engage U.S. regulatory authorities, industry, and professional associations at the policy level.
• Leverage key relationships with FDA staff and industry and trade association colleagues to advance Amgen’s position related to regulatory policy.
• Coordinate the implementation of new U.S. regulatory policy and guidance across Amgen functions.
• Engage cross‑functional teams to develop strategic/long‑term plans for the development and implementation of policies.
• Lead the development and execution of strategic plans for each assigned policy area such as Chemistry, Manufacturing, and Controls (CMC), Precision Medicine, and Combination Products.
• Ensure that Amgen’s regulatory policy positions are successfully represented to inform policy development and implementation.
• Foster a reputation with regulators as being science‑based, reliable and trustworthy by advocating sound policies.
• Provide internal stakeholders (e.g., Global Government Affairs, R&D, Commercial, Legal) with a strategic regulatory policy perspective.
• Assist and advise senior leadership in selecting issues, establishing priorities and developing and implementing regulatory policy advocacy plans.
• Assist in creating the necessary infrastructure/processes for developing the regulatory policy and intelligence function.

What We Expect Of You

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.

Basic Qualifications

• Doctorate degree and 4 years of related experience.
• or Masters degree and 7 years of related experience.
• or Bachelor’s degree and 9 years of related experience.

What You Can Expect Of Us

We work to develop treatments that take care of others, while also caring for your professional and personal growth and well‑being. From our competitive benefits to our collaborative culture, we 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, comprising of:

• 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.

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.

Equal Opportunity Statement

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. We are 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.