Executive Director, Regulatory Affairs

Career Category

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. 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

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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

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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