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.

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

Live

What you will do

Let’s do this. Let’s 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 Amgen’s 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.

• 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

Win

What we expect of you

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

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 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

Ready to Apply for the Job?

We highly recommend utilizing Workday's robust Career Profile feature to complete the application process. A link to update your profile is available when you click Apply. You can then complete your Workday profile in minutes with the “Upload My Experience” functionality to upload an updated copy of your resume or you can simply edit the individual sections of your Career Profile.

Please note that you should be in your current position for at least 18 months before applying to internal positions. Staff must notify their current manager if invited for an interview. In addition, Staff are ineligible to apply for open positions if (a) their performance is currently being managed on a performance improvement plan (PIP) or other locally utilized formal coaching document or (b) their most recent performance rating was not a “Partially Meets Expectations” or higher. Please visit our Internal Transfer Guidelines for more detailed information

GCF Level

Career Category

Position Type