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We found 6 Regulatory Affairs jobs in Ashburn



Regulatory Affairs in Ashburn

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Regulatory Affairs Specialist

I-Mab Biopharma - Washingtonian Industrial Park, MD

Posted 6 days ago


* Format documents including IND/BLA/NDA/ sections, protocols, amendments, investigator brochures, meeting packages, etc. for regulatory submissions.

* Assist regulatory group in the submission of regulatory documents and performs quality control review of final documents to regulatory agency.

* Assist to ensure document quality and timeliness and identify, assess, and resolve or escalate any risks or issues that could affect the successful completion of regulatory submissions/timelines.

* Develop and maintain regulatory document processing and regulatory submission publishing standards and procedures (SOPs)


* Manage all regulatory submission publishing deliverables on a day-to-day basis to ensure successful execution of operational activities

* Work independently to drive publishing process for routine submissions and proactively identifies and escalates publishing issues as necessary.

* Regulatory document level publishing including: editing, formatting (MS Word: styles, captions, cross-references, tables, etc.), conversion of files to required standards, Adobe PDF processing: book marking; hypertext linking; and quality control checks.

* Submission level publishing including: eCTD placement and structure within eCTD Modules (1-5), cross-document links, study tagging files (STF), submission quality control (QC), transmission of submissions to US FDA via Electronic Submissions Gateway (Global Submit).

* Archive and document transfer: archival of final word documents and submission sequence, maintain regulatory administrative record (submission calendar, log, etc.)

* Maintain proficiency and expertise with respect to eCTD publishing tools, processes, and regulations associated with global eCTD regulatory submissions.