Vice President Regulatory Affairs, Obesity - Thousand Oaks, United States - Workday

Description

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.

Vice President, Regulatory Affairs - Obesity

Live

What you will do
Let's do this. Let's change the world.

In this vital Vice President role, you will improve patient lives through leadership of the Regulatory Affairs for the therapeutic area of Obesity and Obesity Related Conditions (ORCs).

In this role, the Vice President will provide expertise for the development, registration, and lifecycle management of all our Obesity and ORC molecules.

As well as strategic regulatory influence locally and globally in addition to the development of successful, expedient, and innovative regulatory strategies for development and approval of Amgen products.

Responsibilities
Develops the vision of the Regulatory Therapeutic Area for Obesity and Obesity Related Conditions (ORCs) and drives its execution, ensuring the globalization of strategy and process

Represents the Regulatory Affairs Therapeutic Area (TA) with Amgen executive leadership, governance bodies, regulatory agencies, and external partners

Has oversight of, and is accountable for, all aspects of Regulatory TA strategies, decisions, and implementation plans

Provides timely input to Amgen executive leadership, review committees and other cross-functional product meetings

Advocates for Regulatory Affairs by building strong relationships with key external stakeholders including regulatory agencies and influential professional bodies, and seeks to influence regulatory policy globally

Provides strategic vision to guide the development of new department and cross-functional processes including technology and compliance initiatives

Exchanges regulatory information with other Global Regulatory Affairs and Strategy (GRAAS) leaders on an ongoing basis (e.g., prior to relevant senior management review committees and governance boards)

Prioritizes projects within the TA to meet Corporate and R&D priorities

Accountable for defining and delivering against TA goals and objectives, aligned with corporate, R&D, and GRAAS goals

Reviews and approves alignment of sub-functional goals in RA

Provides managerial leadership and direction to functional heads to facilitate issue resolution and allowing for appropriate prioritization or resources to achieve goals

Ensures staff are compliant with Amgen corporate and departmental training and SOP review

Provides coaching, mentoring, and development of staff

Recruits and retains regulatory professionals and assist in the recruitment of talented GRAAS and AMGEN staff

Develops TA goals in alignment with department goals

Envisions and builds an organization and processes that support future department, company, and industry changes

Responsible for TA budget and headcount

Accountable for disseminating and representing corporate and departmental information to staff and ensuring understanding and adherence to changes

Develops plans for staff created annually and reviewed quarterly

Conducts regular functional governance meetings

Responsible for thorough staff and organizational development including effective Talent Management, Succession Planning and Maximizing Amgen Potential (MAP) Process

Responsible for organizational management through ERP tools, expense report reviews, invoice approvals, timecard review and approval, overtime approval, vacation requests, etc.

Win

What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The professional we seek is a leader with these qualifications.

Basic Qualifications
Doctorate degree & 8 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

8 years of direct managerial experience. Previous experience managing other managers

Preferred Qualifications
PhD with 8 years of industry experience and management experience

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 $307,500 - $512,500.

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.

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Salary Range
387,860.00 USD - 450,000.00 USD
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