Amgen Senior Associate - Regulatory Affairs in Los Angeles, 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.
Senior Associate - Regulatory Affairs
What you will do
Let’s do this! Let’s change the world. In this key role you will work closely with the Regulatory Affairs Manager to run Amgen's Global Regulatory Commenting Process. This role involves extensive cross-functional collaboration and interaction with Amgen staff at many levels within the company
Scan daily email subscriptions and search results from intelligence services to identify regulatory documents relevant to the business
Apply prior knowledge of drug development or training provided to route documents to the appropriate Amgen subject matter experts for review and possible commenting
Establish and support global regulatory commenting teams, set-up SharePoint sites for group editing of documents, and run commenting team meetings
Understand and apply commenting principles to ensure that Amgen comments are thoughtful, professional, and thorough
Maintain accurate tracking of all current and past commenting activities through SmartSheet; assist the Regulatory Policy Manager in communicating accurate weekly reports of ongoing commenting activities to stakeholders across the company
Provide similar support for other high priority working groups, as well as other regulatory projects as assigned
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The highly competent professional we seek is a go-getter with these qualifications.
Master’s degree and Regulatory or Drug Development experience; OR Bachelor’s degree and 2 years of Regulatory or Drug Development experience; OR Associate’s degree and 6 years of Regulatory or Drug Development experience; OR High school diploma / GED and 8 years of Regulatory or Drug Development experience
Master’s degree in a biology, biotechnology, chemistry, or other health or life science curriculum
Regulated pharmaceutical/ biotechnology industry experience
Good communication skills - both oral and written
Organizational skills - detail oriented and can manager multiple ongoing projects at once
Some of the vast rewards of working here
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.
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.
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.
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 requires all staff in the United States, Puerto Rico and Canada to be vaccinated from COVID 19 as a condition of employment. In accordance with applicable law, Amgen will provide reasonable accommodations to staff members who qualify on the basis of a medical reason or a sincerely held religious belief, practice, or observance. Such accommodation may not pose an undue hardship to Amgen, its operations, or its staff.