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Regulatory Affairs Manager

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Amgen

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Location:
Ireland , Dun Laoghaire

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Category:
IT - Administration

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Contract Type:
Not provided

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Salary:

Not provided
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Job Description:

The Regulatory Affairs Manager at Amgen ensures the company’s compliance with all regulations and laws pertaining to the company’s business. They work with federal, state, and local regulatory agencies on issues and regulations that affect the company’s products and services. 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.

Job Responsibility:

  • Provide CMC regulatory strategy for assigned projects by defining minimal regulatory filing requirements, submission strategy, and regulatory risk assessments
  • Support 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

Requirements:

  • Doctorate Degree
  • Master's Degree and 3 years of Regulatory CMC or related technical experience
  • Bachelor's Degree and 5 years of Regulatory CMC or related technical experience
  • Associates degree and 10 years of Regulatory CMC or related technical experience

Nice to have:

  • 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
What we offer:
  • 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

Additional Information:

Job Posted:
May 13, 2026

Employment Type:
Fulltime
Work Type:
Hybrid work
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