Regulatory Affairs Manager

4 weeks ago

Albany, New York, United States Amgen Full time

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.

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 products. This position will be responsible for the strategy and execution of the site-specific aspects of the preparation of CMC investigational product amendments and post-market supplements, organization and preparation CMC sections of IND annual reports and annual reports of minor changes for specific products; acts as key RA CMC representative on product deviation investigation teams, participates in site change control teams

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.

  • Facilitate product development, global registration by developing and executing regulatory strategies and effective regulatory agency interactions for product manufacturing and quality programs throughout product lifecycle.
  • Provide CMC regulatory strategy for products manufactured at or planned for the specific site.
  • Interface with the site (R&D and operations authors) coordinate preparation of regulatory filings, identification of issues and factors that may implicate a regulatory strategy or activity.
  • Support Change Management activities
  • Monitor and, as necessary, provide data to be entered into tracking systems for department deliverables and ensure information is current.

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:

  • Regulatory CMC knowledge and experience
  • Experience in manufacture, testing (QC/QA, distribution, 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, we also 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

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