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Amgen Global Regulatory Operations – Regulatory Data & Analytics – Senior Associate in Thousand Oaks, California


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.

Global Regulatory Operations – Regulatory Data & Analytics – Senior Associate


What you will do

Let’s do this. Let’s change the world. In this vital role you will ensure the smooth compliant flow of information between all Functional areas, internal and external to GRAAS, local offices, external partners and regulatory authorities.

  • Maintain Regulatory document management and tracking systems.

  • Create/archive Clinical Trial and Marketing Application submissions/Health Authority correspondence

  • Responsible for maintaining the on-site hard copy Regulatory archive and overseeing incoming/outgoing off-site Regulatory document storage.

  • Point of contact between Regulatory Representatives/CMC and publishing teams.

  • Manage the Protocol Amendment New Investigator (PANI) submissions and PI updates/additions.

  • Ensuring Regulatory compliance with SOPs and Regulatory authorities

  • Provide training, mentoring and support to RDA team members and other functional areas, including vendors.

  • Collaboration with external partners/outsourced CROs

  • Run 1572 forms for FDA submission.


What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The Dynamic professional we seek is a go-getter with these qualifications.

Master’s degree


Bachelor’s degree and 2 years of directly related experience


Associate’s degree and 6 years of directly related experience


High school diploma / GED and 8 years of directly related experience

  • Industry experience

  • Experience in an operationally-focused role within Regulatory Affairs


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

Apply now 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.

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.​