Amgen

Regulatory Affairs Manager, CMC (US-Remote)

Employer
Amgen
Location
Los Angeles, CA
Posted
Jan 21, 2022
Ref
R-128597
Required Education
Associate Degree
Position Type
Full time

HOW MIGHT YOU DEFY IMAGINATION?

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.

Regulatory Affairs Manager, CMC (Chemistry, Manufacturing and Controls)

Live

What you will do

Lets do this. Lets change the world. In this vital role you will provide regulatory strategy for lifecycle management (Commercial) products. This position would primarily support clinical trials of Amgens marketed products globally, but would also support post-approval change management activities in the US, EU, CN and JP. The Manager will follow standard department and global marketing/clinical trial template processes to drive consistency and efficiency across programs.

Win

What we expect of you

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

  • Provide CMC regulatory strategy for assigned projects by defining minimal regulatory filing requirements, submission strategy and regulatory risk assessments
  • Development of global dossiers for CMC content of new clinical trials, or amendments to existing CTAs for marketed products
  • Development of post-approval submissions including maintenance of applications for US, CA, CN and/or JP
  • Support Change Management activities
  • Respond to regulatory agency questions
  • Liaise with other Functions in development, operations, and commercial to ensure alignment of global regulatory strategies, timing, execution and supply plans
  • Monitor and, as necessary, provide data to be entered into tracking systems for department deliverables and ensure information is current
  • Participate as an active member of cross-functional teams including GRT, PDT, PQT, etc, as needed
Basic Qualifications:
  • Doctorate Degree Or
  • Master's Degree and 3 years of Regulatory CMC or related technical experience Or
  • Bachelor's Degree and 5 years of Regulatory CMC or related technical experience Or
  • Associates degree and 10 years of Regulatory CMC or related technical experience
Preferred Qualifications:
  • Degree in Life Science
  • Regulatory CMC knowledge and experience with small molecule and/or Biologic products
  • Experience in manufacture, testing (QC/QA or clinical), process development or other related Pharmaceutical/Biotech industry
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 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.

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.

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.