Regulatory Affairs Manager (CMC Site)

Amgen Inc.

3.6

(9)

Multiple Locations

Why you should apply for a job to Amgen Inc.:

  • 67% say women are treated fairly and equally to men
  • 78% would recommend this company to other women
  • Ratings are based on anonymous reviews by Fairygodboss members.
  • Flexible work models that empower staff members to work where and when they are most productive
  • Award-winning PTO plan and bi-annual company-wide shutdowns
  • With 11 Employee Resource Groups, 60 chapters & 11000 members everyone has opportunity to connect, network & foster a culture of belonging
  • #R-188285

    Position summary

    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

    Salary Range
    104,616.00 USD - 134,871.00 USD

    Why you should apply for a job to Amgen Inc.:

  • 67% say women are treated fairly and equally to men
  • 78% would recommend this company to other women
  • Ratings are based on anonymous reviews by Fairygodboss members.
  • Flexible work models that empower staff members to work where and when they are most productive
  • Award-winning PTO plan and bi-annual company-wide shutdowns
  • With 11 Employee Resource Groups, 60 chapters & 11000 members everyone has opportunity to connect, network & foster a culture of belonging