If you feel like you’re part of something bigger, it’s because you are. 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. We are global collaborators who achieve together—researching, manufacturing and delivering ever-better products that read over 10 million patients worldwide. It’s time for a career you can be proud of. Join us.

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 synthetics (Small Molecule) products. This position would primarily support Amgen’s marketed products globally, as a Principal Regulatory Affairs CMC lead. 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 marking applications (MAA), new clinical trials (CTA), variations and amendments to existing MAA/ CTAs.

• Development of post-approval submissions including maintenance of applications

• Support Change Management activities

• Respond to regulatory agency questions

• Liaise with the Global RA CMC product lead, ROOTS representatives, and other functions in development, operations, and commercial to ensure alignment of global regulatory strategies and timing, execution

• 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

Be part of our team

You would be joining the Lifecycle Management (LCM) Center of Excellence for synthetic molecules under the RA CMC Department. We are global team which predominantly operates from Thousand Oaks, with remote team members across the US and Puerto Rico, as well as Uxbridge in the UK. This RA CMC team is part of the Global Regulatory Affairs and Strategy (GRAAS) organization under the Amgen Research and Development Division.

We all work together to serve every patient every time by meeting the demands of an industry-leading, fast paced organization. We keep a commitment to innovation and quality in all that we do; whilst delivering sound RA CMC strategies and submission documents for maintaining the compliance of current Marketing Applications related to Amgen’s synthetics molecule portfolio.

WIN

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. What we seek in you as an experienced professional, are these qualifications and skills:

• Bachelors degree or equivalent in Life Science

• Regulatory CMC knowledge and experience with small molecule and/or Biologic products

• Experience in manufacturing, testing (QC/QA or clinical), process development or other related Pharmaceutical/Biotech industry

LOCATION Ability to work fully remote, or, if situated near an office, the option to work flexibly from home with occasional office presence at our Cambridge or Uxbridge next-generation workspace.

THRIVE

What you can expect of us

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.

• Vast opportunities to learn and move up and across our global organization

• 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

Apply now

Objects in your future are closer than they appear. Join us.

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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.