Remote Senior Associate Regulatory Affairs Operations (Publisher)

Planet Pharma

Reference: 630660Posted: 2026-09-03Location: Remote, IllinoisCompany: Planet Pharma GroupContact: ApplicationsEmail: View email address on click.appcast.io 55-60/h depending on experienceSubmission readiness, publishing, validation, QC review, document formatting, template creation, and hyperlinking (45%)Archiving/closeout of submission sequences (20%)Archives HA correspondence (including emails, letters, faxes, contact reports and OPDP submissions) in US archive and EDMS (15%)Supports document retrieval as requested (electronic and paper); Supports inspections re: document requests as needed (5%)Creation and maintenance of SPL for Drug Establishment, Drug Listing, PI (according to HL7 standards) (5%)Delivery of metrics and reporting compliance (5%)Support development and implementation of global IT tools (Smartsheet, Veeva, eCTD 4) (5%)

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