Executive Director, Regulatory Affairs

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. 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.

Executive Director of Regulatory Affairs

Live

What you will do

Let’s do this. Let’s change the world. In this vital role as Executive Director of Regulatory Affairs, you will direct regulatory affairs activities within an assigned disease area, ensuring compliance with applicable laws and regulations.   You will also provide strategic direction and leadership to the regulatory affairs team.

The Executive Director of Regulatory Affairs is a product facing role that leads a designated part of the Inflammation and Rare Disease Global Regulatory Therapeutic Area in the Global Regulatory Affairs organization.

This role will report into the Vice President, Global Regulatory Affairs

Responsibilities:

• Provide management and leadership of regulatory strategy within the assigned therapeutic area for Global Regulatory Affairs

• Direct the development of global and United States regulatory therapeutic area and product regulatory strategies to drive product development, global registration, achievement and maintenance of desired regional labeling, and effective regulatory agency interactions

• Provide regulatory expertise and guidance to therapeutic area commercialization teams and other governance bodies

• Advise the Global Regulatory Leader (GRL) in the development of global regulatory strategies and the United States Regulatory Leader (USRL) in the development of US regulatory strategies, including precedence, risk management and contingency planning

• Conduct management review and approval of Global Regulatory Strategic Plans

• Conduct review and approval of key documents for regulatory submissions

• Contribute to the target product label, core data sheet, and regional labeling

• Monitor, assess and communicate to staff impact of relevant global regulations, guidance, and current regulatory environment

• Advise on global health authority interactions and participate on core regulatory and cross-functional teams to ensure effective agency interactions

• Work externally to influence regulatory legislative environment in line with Amgen policy priorities for the therapeutic area

• Oversee and participate in licensing/acquisition due diligence and other activities in partnership with Amgen licensing groups

• Provide managerial leadership & direction to staff within assigned area allowing appropriate prioritization of resources to achieve goals

• Recruit and retain talented regulatory affairs professionals.

• Provide coaching, mentoring, and career development of staff

• Ensure staff are compliant with Amgen corporate and departmental training

• Communicate and ensure alignment of global functional and cross-functional goals and objectives

Knowledge and skills include:

• Demonstrated ability to lead teams

• Strong communication skills - both oral and written

• Ability to understand and communicate scientific/clinical information

• Comprehensive understanding of regulatory activities and how they affect projects and processes

• Demonstrable ability to set organizational direction & champion change and continuous improvement

• Proven ability to anticipate and mitigate against future strategic issues & uncertainties

• Ability to resolve conflicts and develop a course of action leading to a beneficial outcome

Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The candidate we seek is an experienced leader with the following qualifications.

Basic Qualifications:

• Doctorate degree & 6 years of regulatory affairs experience OR

• Master’s degree & 10 years of regulatory affairs experience OR

• Bachelor’s degree & 12 years of regulatory affairs experience AND

• 6 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources

They will also embody the Amgen leadership attributes which are:

• Inspire: Create a connected, inclusive, and inspiring work environment that empowers talent to thrive

• Accelerate: Enable speed that matches the urgency of patient needs by encouraging progress over perfection

• Integrate: Connect the dots to amplify the collective power of Amgen to drive results for patients, staff, and shareholders

• Adapt: Lead through change by adapting to an ever-changing environment and defining a clear course of action to deliver results

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, we’ll support your journey every step of the way.

The annual base salary range for this opportunity in the U.S. is $265,569 - $309,299.

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:

• 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

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 with 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 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.