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Senior Regulatory Specialist

VirtualVocations
Portland, OR Full Time
POSTED ON 3/1/2025
AVAILABLE BEFORE 5/25/2025

A company is looking for a Senior Regulatory Specialist to optimize their Biopharma / Regulatory Affairs organization.Key ResponsibilitiesMaintain knowledge of global regulations and guidance documentsReview regulatory changes and evaluate quality / regulatory impactDevelop responses to regulatory deficiencies and collaborate with cross-functional teamsRequired QualificationsBachelor's Degree in relevant fields; MS in Regulatory Sciences preferredMinimum of 2 years of experience in a regulated industryExperience with eCTD format and regulatory affairs processesWorking knowledge of 21 CFR 210 / 211, ICH Q7, and / or IPECRAC Certification is a plus

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