Sr Associate GRAAS Operations

Thousand Oaks, CA
Jul 19, 2021
Required Education
High School or equivalent
Position Type
Full time


Youve earned your degree. How will you use that achievement to reach your goals? Do more with the knowledge youve worked hard to acquire and the passion you already have. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies, reaching over 10 million patients worldwide. Become the professional you are meant to be in this meaningful role.

Title: Senior Associate- GRAAS Operations


What you will do

Lets do this. Lets change the world. In this vital role you will

Creation and submission of regulatory dossiers according to agency requirements, eCTD Guidance & Specifications and agreed upon timelines

Preparation of submission ready components from internal contributors according to regional regulatory guidance and internal standards

Contribution to submission strategy and timing

Contribution to the filing of ex-US regional submissions

Development of global training and documentation for publishing

Creation and maintenance of technical manuals, training documentation and SOPs

Participation in information system and software update projects as well as ongoing system validations

Interaction with vendor and supplier staff

Supervision of contractors in the conduct of their duties

Knowledge and Skills:

Experience working in and leading teams

Understanding of the industry and business principles for a regulatory operations department

Advanced knowledge of the regulations and regulatory guidance applicable to global Clinical Trial and Marketing Applications

Advanced knowledge of the submission and maintenance of global Clinical Trial and Marketing Applications

Advanced knowledge of eCTD, eCTD Specifications and eCTD software

Advanced knowledge of MS Word, Adobe Acrobat and a variety of Acrobat related plug-ins specific to regulatory publishing


What we expect of youWe 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.

Basic Qualifications:

Masters degree


Bachelors degree and 2 years of directly related experience.


Associates degree and 6 years of directly related experience


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


  • Industry experience
  • Experience in a regulatory operations-focused role
  • Advanced experience publishing eCTD submissions
  • Advanced experience with standard software utilized by regulatory publishing groups.

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 Plancomprising health, finance and wealth, work/life balance, and career benefitswith 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.