Regulatory Affairs Specialist
Full Time - 40 hours a week
ONSITE - Springfield, MA, US
Summary: The Regulatory Affairs Specialist (Level 2) independently manages regulatory submissions, communications, and documentation across multiple studies at clinical research sites. This mid-level position requires an in-depth understanding of FDA, ICH-GCP, HIPAA and IRB requirements as well as proficiency in regulatory software tools and CTMS.
This job description is not an exhaustive list of all the functions that you may be required to perform. The Company reserves the right to revise this job description at any time.
Requirements:
Continuing Education:
Physical Requirements and Environmental Factors:
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