Amgen US Regulatory Affairs Sr Manager- Oncology in Thousand Oaks, California
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. Join us.
US Regulatory Affairs Sr Manager
What you will do
Let’s do this. Let’s change the world. In this vital role you will support one or more products from a regional regulatory perspective, achieve desired labeling by developing and executing regional regulatory strategies, and leading effective agency interactions.
To advise the GRT on regional considerations in developing strategy
To ensure the regional needs are well defined and implemented in collaboration with relevant regional partners
To ensure that Amgen acquires and maintains all the required licenses in order to support clinical trials for investigational medicinal products as well as market commercially approved medicinal products in compliance with local laws and regulations and Amgen standards
To ensure regulatory compliance, with a focus on patient safety
Represent regional regulatory affairs as a member of the GRT, Evidence Generation Team (EGT), Clinical Study Team (CST), Label Working Group (LWG), and/or Regional Teams
Plans and handles regulatory submissions (e.g. clinical trial and marketing applications) for products within Amgen's portfolio in compliance with global filing plans and local regulatory requirements
Implements product related regulatory strategies, Regulatory Affairs processes and activity planning in accordance with national legislation and regulatory requirements
Leads development of regional regulatory documents (including labels) and meetings in accordance with GRT strategy
Provides regulatory direction on regional regulatory mechanisms to optimize product development (e.g. expediting FIH studies, Orphan Drug Designation, expedited regulatory designations (eg, Breakthrough therapy), Fast Track, compassionate use and pediatric plan)
Advises the development of the regional product label by collaborating with the Labeling Working Group to define commercial objectives in the context of available and expected scientific data, regulatory guidance and precedent
Manages regional label submission strategy and timelines, negotiation activities and deviation requests.
With minimal direction, participate in the development and execution of regional regulatory product strategies, including precedence, risk management and contingency planning
Consistent with GRT strategy, advise EGT on regulatory implications and requirements related to global clinical development plans and objectives
Share regulatory information and implications with the GRT colleagues on an ongoing basis and provide advice on regional considerations
Participate in LWG meetings with advice on local deviation requests
Communicate and ensure alignment of regional management before GRT strategy decisions
Partner with regional management and peers to ensure consistency in procedures and agency interactions
What we expect of you
We are all different, yet we all use our outstanding contributions to serve patients. The professional we seek is a team-player with these qualifications.
Doctorate degree and 2 years of experience OR
Master’s degree and 6 years of experience OR
Bachelor’s degree and 8 years of experience OR
Associate’s degree and 10 years of experience Or
High school diploma / GED and 12 years of experience
Regulatory experience (relevant years as outlined above)
Contemporary Oncology Regulatory experience
Regulatory knowledge in national regulations
Working with policies, procedures and SOP’s
Experience with national legislation and regulations relating to medicinal products
Understanding of the registration procedures in region for MA, post approval changes, extensions and renewals
Understanding of drug development
Good communication skills - both oral and written
Ability to understand and communicate scientific/clinical information
Ability to anticipate and prevent potential issues
Communication of regulatory strategies such that expectations are understood
Anticipate regulatory agency responses to strategy
Strong understanding of and experience in regional regulatory environment in relevant product area and development stage
Comprehensive understanding of regulatory activities, touch points and how they affect projects and processes
Ability to resolve conflicts and develop a course of action leading to a beneficial outcome
Cultural awareness and sensitivity to achieve results across both regional country and International borders.
Regulatory submissions experience, experience interacting with regulatory agencies
What you can expect of us
As we work to develop treatments that take care of others, so we work to care for our teammates’ professional and personal growth and well-being.
Vast opportunities to learn and move up and across our global organization
Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits
for a career that defies imagination
In our quest to serve patients above all else, Amgen is the first to imagine, and the last to doubt. Join us.
Equal Opportunity Statement
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 a 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 an accommodation.
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 cancer, 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.