Regulatory Affairs Director - Oncology (Open To Remote)

HOW MIGHT YOU DEFY IMAGINATION?
If you feel like you're part of something bigger, it's because you are. At Amgen, our shared mission-to serve patients-drives all that we do. It is key to our becoming one of the world's leading biotechnology companies. We are global collaborators who achieve together-researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. It's time for a career you can be proud of.
Regulatory Affairs Director - Oncology (open to remote)
Live
What you will do
Let's do this. Let's change the world. In this key role you will be the Global Regulatory Leader (GRL) is a product facing role in which you will lead the Global Regulatory Team (GRT) in the Oncology therapeutic area. The purpose of this role is:

• To lead a team within Amgen's Global Regulatory Affairs department
• To develop a comprehensive regulatory strategy that takes into account worldwide regulatory requirements to drive product development, global registration, achievement and maintenance of desired regional labeling, and effective regulatory agency interactions
• To provide regulatory expertise and guidance to product teams (eg, Product Team (PT), Evidence Generation Team (EGT), Global Safety Team (GST).

Responsibilities include:

• Develop and implement the global regulatory product strategy
• Lead Global Regulatory Teams within the Amgen Regulatory Affairs department
• Represent Global Regulatory Affairs on the PT and key commercialization governance bodies
• Develop registration strategies and plans aimed at achieving regulatory approval and product labeling
• Provide direction in the development of the core datasheets to align commercial objectives in the context of available and expected scientific data, regulatory guidance, and precedent
• Lead the planning and implementation of global regulatory filings (e.g. clinical trial applications, marketing applications, label extensions, CMC changes)
• Ensure consistency of evidence-based global product communication (e.g., regulatory submission documents)
• Monitor and assess impact of relevant global regulations, guidance, and current regulatory environment
• Ensure guidance on regulatory mechanisms to optimize product development (e.g. expediting FIH studies, Orphan Drug, Fast Track, conditional /accelerated approval, compassionate use, and pediatric plan) is assessed and incorporated into the global regulatory strategy
• Communicate consistently well-defined, successful regulatory strategies throughout the organization such that expectation is understood
• Ensure effective agency communications by leading core regulatory and cross functional teams (e.g., GRTs, filing teams)
• Attend key regulatory agency meetings which could impact the global product strategy
• Represent Amgen Regulatory on external partnership teams at the product level

Win
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The highly competent individual we seek is a go getter with these qualifications.
Basic Qualifications:

• Doctorate degree and 4 years of regulatory experience in biotech or science , OR
• Master's degree and 8 years of regulatory experience in biotech or science, OR
• Bachelor's degree and 10 years of regulatory experience in biotech or science

Preferred Qualifications:

• Contemporary oncology experience desired
• Ability to lead and build effective teams
• Strong communication skills - both oral and written
• Ability to understand and communicate scientific/clinical information
• Ability to anticipate and mitigate against future strategic issues & uncertainties
• Ability to resolve conflicts and develop a course of action
• Cultural awareness and sensitivity to achieve global results
• Planning and organizing abilities
• Able to prioritize and manage multiple activities
• Ability to make complex decisions and solve problems
• Ability to deal with ambiguity

Thrive
What you can expect of us
As we work to develop treatments that improve the health 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$185,618 - 225,774.
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

Apply now for a career that defies imagination
Objects in your future are closer than they appear. Join us.
careers.amgen.com
Join Us
If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.
Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancers, kidney disease, rheumatoid arthritis and other serious illnesses.
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 but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.
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, 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.