Senior Regulatory Affairs CMC Associate
Company: VirtualVocations
Location: Pasadena
Posted on: September 2, 2024
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Job Description:
A company is looking for a Senior Regulatory Affairs CMC
Associate.
Key Responsibilities:
Support management of CMC dossier content submissions for clinical
and commercial applications
Independently plan and prepare routine clinical trial application
related amendments and commercial submissions
Maintain submission trackers for coordination of submissions across
multiple products
Required Qualifications:
BS degree required; advanced degree (PharmD, PhD, Master's)
preferred
Minimum 5 years' experience in regulatory affairs or related
function in drug/biologic development
Experience in managing regulatory submissions for investigational
or marketed products in eCTD format
Understanding of US and Ex-US regulations in drug/biologics
development
Familiarity with ICH eCTD structure and major market post approval
change requirements
Keywords: VirtualVocations, Pasadena , Senior Regulatory Affairs CMC Associate, Other , Pasadena, California
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