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Amgen Global Regulatory Operations – Submission Management - Senior Associate in Thousand Oaks, 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.

Global Regulatory Operations – Submission Management - Senior Associate

Live

What you will do

Let’s do this! Let’s change the world. This vital role will lead the creation of regulatory submissions through detailed planning and delivery of regulatory submission components and product dossiers.

Key Activities

  • 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, supplier staff and 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, MS Word, Adobe Acrobat and a variety of Acrobat related plug-ins specific to regulatory publishing

Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The senior associate we seek is a professional with these qualifications.

Basic Qualifications:

  • Master’s degree or

  • Bachelor’s degree and 2 years of directly related experience or

  • Associate’s degree and 6 years of directly related experience or

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

Preferred Qualifications:

  • Industry experience

  • Experience in a regulatory operations-focused role

  • Advanced experience publishing eCTD submissions

  • Advanced experience with standard software utilized by regulatory publishing groups

  • Experience with Ad/Promo Submissions

Thrive

Some of the vast rewards of working here

As we work to develop treatments that look after 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 improve 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!

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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.

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