Executive Director, Regulatory Affairs

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Executive Director, Regulatory Affairs

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remote type

Remote

locations

US - California - Los Angeles

time type

Full time

posted on

Posted 2 Days Ago

job requisition id

R-190059

Career Category

Regulatory

Job Description

HOW MIGHT YOU DEFY IMAGINATION?
At Amgen, every challenge is an opportunity. And every opportunity brings the potential to change lives. Our shared mission—to serve patients—has driven our status as one of the world’s preeminent biotechnology companies, reaching over 10 million patients worldwide. Leverage your high-level expertise to lead and forge partnerships that advance the biotechnical and biopharmaceutical science that can turn the tide of serious, life-interrupting illnesses.
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’s, 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 our teammates’ professional and personal growth and well-being.
The annual base salary range for this opportunity in the U.S. is $259,141 - $300,862
In addition to the base salary, Amgen offers a Total Rewards Plan comprising 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 including:
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

Amgen’s Commitment to Our Staff
At Amgen, our mission is serving patients. Our staff are dedicated to pushing the boundaries of science to transform medicine and turn the tide on serious illnesses. Central to achieving this mission is our “people-first” philosophy.
We recruit the best talent, build an environment that facilitates career growth, and provide staff with the opportunity to make significant contributions for patients and our business.
We equip all our staff members to live well-rounded, healthy lives. Most recently, Amgen added benefits for transgender employees and continues to pride itself on industry-leading, family-friendly offerings for families of all compositions.
Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
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.
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.
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Salary Range
259,141.00 USD - 300,862.00 USD
About Us

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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