Regulatory Policy and Intelligence Associate Director

Career Category Regulatory Job Description

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. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions. 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 Associate Director

What you will do Let’s do this. Let’s change the world. The Regulatory Policy and Intelligence team advances important policy issues, aligned with Amgen’s goals and priorities, by engaging externally with regulators, industry trade associations, consortia and other stakeholders, along with internal subject matter experts across Amgen. In this vital role, you will lead the development and articulation of Amgen's positions on regulatory policies that impact Amgen's business within a defined portfolio, exercising independent judgement and driving cross-functional alignment. You will report to the Amgen’s U.S. Lead for Regulatory Policy and Intelligence.

Primary Responsibilities

• Foster U.S. trade association relationships and provide stewardship over the company’s regulatory and R&D-related trade association engagements.
• Staff company executives in leadership roles in domestic and international forums.
• Develop and lead enterprise-wide regulatory reform initiatives; implement strategies to shape policy outcomes, the external environment and identify related internal business needs for implementation.
• Lead assigned policy initiatives from analysis and position development through external engagement and implementation, in partnership with policy leads and management.

Additional Responsibilities

• Partner with policy leads and subject matter experts, including Government Affairs, R&D, Operations, and other relevant stakeholders, to develop advocacy materials on priority policy issues.
• Prepare presentations and other communications to support alignment on positions and strategies across the Amgen organizations and regions.
• 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 positions and impact assessments.
• Plan and help manage projects for agreed upon policy objectives under the direction of and 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 3 years of regulatory experience OR Master’s degree and 5 years of related experience OR Bachelor’s degree and 7 years of regulatory experience OR Associate’s degree and 12 years of regulatory experience OR High school diploma / GED and 14 years of regulatory experience

Preferred Qualifications

• Doctorate or Master’s degree (scientific area)and 10 years of directly related regulatory policy experience, including FDA and international regulators.
• Bachelor’s degree (scientific area) and 12 years of directly related experience.
• In-depth knowledge and demonstrated policy leadership with U.S. legislation and regulations relating to medicinal products.
• Trade association or consortia experience.
• 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 capacity to work well with people at all levels of the organizing in demanding situations with a positive attitude, tact, diplomacy, and respect.
• Demonstrated ability to work in a fact-paced environment with retaining a high attention to detail and quality.
• Excellent organization, process, and project management skills.

Salary and Benefits

The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is $155,365 - $210,199. 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.

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Application Deadline

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 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.

Equal Opportunity

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.

Company Overview

Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology. Amgen focuses on areas of high unmet medical need and leverages its biologics manufacturing expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.

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