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Senior Regulatory Specialist - Fort Collins Colorado

Company: VirtualVocations
Location: Fort Collins, Colorado
Posted On: 02/07/2025

A company is looking for a Senior Regulatory Specialist to optimize their Biopharma/Regulatory Affairs organization.



Key Responsibilities

Maintain knowledge of global regulations and guidance documents
Review regulatory changes and evaluate quality/regulatory impact
Develop responses to regulatory deficiencies and collaborate with cross-functional teams


Required Qualifications

Bachelor's Degree in relevant fields; MS in Regulatory Sciences preferred
Minimum of 2 years of experience in a regulated industry
Experience with eCTD format and regulatory affairs processes
Working knowledge of 21 CFR 210/211, ICH Q7, and/or IPEC
RAC Certification is a plus More...

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