Sr Associate Regulatory Affairs - CMC (x2)

Career Category Regulatory Job Description

HOW MIGHT YOU DEFY IMAGINATION?

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 reach over 10 million patients worldwide. It’s time for a career you can be proud of. Join us.

What you will do

Regulatory Affairs, Chemistry, Manufacturing and Controls (RA CMC) facilitates product development and global registration by developing and executing regulatory strategies and managing effective regulatory agency interactions for product manufacturing and quality programs throughout product lifecycle.

Amgen is searching for a Senior Associate to join the ROOTS2 group within RA CMC. The ROOTS2 team supports CMC submission execution for Amgen products across phases of development, modality and countries. The RA CMC Senior Associate will interface with the Amgen global, international, site and biosimilars RA CMC teams and the device team for specific strategies or activities that impact a product. You will be responsible for varying levels of product support, including leading projects, based upon their experience level.

Key responsibilities include:

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• Contribute as a key member of the global regulatory CMC product team
  
• Interact with authors/reviewers and subject matter experts with respect to delivery of regulatory documents required for regulatory submissions
  
• Contribute to the organization and preparation of CMC investigational product amendments, post‑market supplements/variations, and new marketing applications
  
• Document and archive CMC submissions and related communications in the document management system
  
• Initiate and maintain CMC product timelines at the direction of product lead
  
• Interface with the regulatory operations team
  
• Train staff on select CMC procedures and systems
  
• Provide report status of activities and projects to teams and department
  
• Participate in cross-functional special project teams
  

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:

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• Relevant Bachelor’s degree or equivalent is essential
  
• Experience in manufacture, process development, quality assurance, quality control, or analytical development
  
• Regulatory CMC specific knowledge and experience
  
• Developed project management and organizational skillsStrong and effective oral and written communication skills
  

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.

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• 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