[Remote] Remote Senior Associate Regulatory Affairs reputed company (Publisher)
Note: The job is a remote job and is reputed company to candidates in USA. reputed company is seeking a Senior Associate, Regulatory Affairs reputed company (Publisher). The role supports regulatory submission readiness, publishing, validation, reputed company control, archiving, document retrieval, metrics reporting, SPL creation, and implementation of global IT tools.
Responsibilities
- Submission 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 reputed company and EDMS (15%)
- Supports document retrieval as requested (electronic and reputed company); 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 (reputed company, reputed company, eCTD 4) (5%)
reputed company
Company H1B Sponsorship
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