Sr. Regulatory Associate

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.

Sr. Associate Regulatory Affairs

Live

What you will do

Let's do this. Let's change the world. In this vital role you will support the coordination, development and/ or execution of Chemistry, Manufacturing and Controls ("CMC") regulatory registration activities in accordance with Amgen's commercialization strategies and global regulatory plans. The primary responsibilities of this role are to support the planning and execution of the site-specific aspects of the CMC registration activities, including facility registrations, working in close collaboration with Site, Global and International CMC and with other functional areas within the site, other Amgen facilities and business partners.

Specific responsibilities include but are not limited to:

  • Support site Regulatory Affairs ("RA") CMC staff, collaborate with the Amgen product teams, regional offices, and/or site teams for specific strategies or activities that impact product registrations.
  • Facilitate product development by supporting global registration and life-cycle management for Amgen products.
  • Works cross functionally with local and global operations and regulatory personnel to coordinate preparation of regulatory filings and other documents used for registration purposes including: New marketing applications; Facility Registration documents; Annual report of minor changes; Country Submission Document ("CSD") Requests.
  • Lead the coordination of registration sample requests, including the resolution of issues that can impact execution.
  • Own and maintain Standard Operating Procedures ("SOPs") and Guidelines related to regulatory registration support activities.
  • Works within Amgen systems for document and change control management.
  • May have additional responsibilities, including leading projects.


Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The Sr. Associate Regulatory professional we seek is an individual contributor with these qualifications.

Basic Qualifications:

Master's degree

Or

Bachelor's degree & 2 years of regulatory affairs experience

Beyond that, the preferred additional qualifications are:
  • Educational background in Biotechnology, Microbiology or Chemistry is preferred
  • Experience in manufacture, quality or distribution in Pharmaceutical/Biotech industry
  • Strong oral and written communication skills in English and Spanish
  • Strong negotiating and leadership skills
  • Experience managing project timelines is desirable
  • Proficiency working with teams at different levels and company locations
  • Able to operate in a fast paced, dynamic environment


Thrive

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.

careers.amgen.com

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.

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.

R-130512