Job Information
Amgen Regulatory Affairs Manager, Document Submission, Veeva Systems Specialist (US-Remote) in Thousand Oaks, California
Regulatory Affairs Manager,
Document Submission, Veeva Systems Specialist (US-Remote)
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.
Live
What you will do
Let’s do this. Let’s change the world. In this vital role you will support regional regulatory activities for the Amgen Biosimilars Operating Unit (BBU) via CTAs/MAAs/BLAs/IMPDs/JNDAs filings and lifecycle management submissions. Provide support for the BBUs Global Regulatory and CMC leads and maintain regulatory documentation.
Provide regulatory systems support for the Amgen Biosimilars Operating Unit.
Support health agency engagements (e.g., U.S. FDA)
Support global filing activities and associated health agency inquiries
Collaborate with multidisciplinary teams and vendors across global regions
Ensure regulatory documents are filed and archived appropriately
Support planning and lifecycle management of submissions
Support project management with CTAs/MAAs/ BLAs filings
Manage document repository of regulatory documentation.
Support regulatory writers with style guide formatting
Win
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The regulatory professional we seek is a strong communicator with these qualifications.
Basic Qualifications:
Master’s degree in Regulatory Affairs, Engineering, or Life Sciences with 2+ years of Regulatory Affairs experience
Bachelor’s degree and 4+ years of combined experience including regulatory affairs, regulatory writing, regulatory device engineering and/or device quality experience, or other related drug-device combination products
Familiarity with medical device software is a plus
Preferred Qualifications:
Robust knowledge of Veeva Systems (Regulatory Information Management and eTMF
Familiarity with medical device software is a plus
Strong written and verbal communication skills
Familiar with cloud base programs such as Box, One Drive, SharePoint
Familiarity with global regulatory submissions
Thrive
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
Apply now
for a career that defies imagination
Objects in your future are closer than they appear. Join us.
careers.amgen.com
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.
Amgen requires all staff in the United States and Puerto Rico 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.
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.