Amgen Regulatory Affairs Lead - US in Thousand Oaks, California
HOW MIGHT YOU DEFY IMAGINATION?
You’ve earned your degree. How will you use that achievement to reach your goals? Do more with the knowledge you’ve worked hard to acquire and the passion you already have. 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, reaching over 10 million patients worldwide. Become the professional you are meant to be in this meaningful role.
Regulatory Affairs Lead - US
What you will do
Let’s do this. Let’s change the world. In this vital role you will contribute as a US Regulatory Lead (USRL). You will support one or more products from a regional regulatory perspective. As a member of the Global Regulatory Team (GRT), they will achieve the desired labeling by developing and executing regional regulatory strategies and leading effective agency interactions.
Develop and execute regional regulatory strategies and lead effective agency interactions
Advise the GRT on regional considerations in developing strategy
Ensure the regional needs are well-defined and implemented in collaboration with relevant regional partners
Ensure that Amgen acquires and maintains all the appropriate 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
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 manages 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
Implement product related regulatory strategies, Regulatory Affairs processes and activity planning in accordance with national legislation and regulatory requirements
Lead development of regional regulatory documents (including labels) and meetings in accordance with GRT strategy
Provide 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)
Direct 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
Lead regional label submission strategy and timelines, negotiation activities and deviation requests.
With minimal supervision, 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
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 interpersonal 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 knowledge 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 an effective outcome
Cultural awareness and sensitivity to achieve results across both regional country and International borders.
Regulatory submissions experience, experience interacting with regulatory agencies
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The type of professional we seek is an ambitious leader with these qualifications.
Doctorate degree OR
Master’s degree and 3 years of Regulatory experience OR
Bachelor’s degree and 5 years of Regulatory experience
Regulatory knowledge in national regulations
Some of the vast rewards of working here
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.
Full support and career-development resources to expand your skills, enhance your expertise, and maximize your potential along your career journey
A 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—with compensation and benefits rated above 4 stars (out of 5) on Glassdoor
for a career that defies imagination
Objects in your future are closer than they appear. 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.