Regulatory Submissions Specialist
Job in
New Haven, New Haven County, Connecticut, 06540, USA
Listed on 2026-09-14
Listing for:
Scorpion Therapeutics
Full Time
position Listed on 2026-09-14
Job specializations:
-
Pharmaceutical
Healthcare Compliance, Regulatory Compliance Specialist
Job Description & How to Apply Below
Role
Regulatory Submissions Specialist responsible for preparing, processing, and submitting regulatory documentation for IND, CTA, BLA, and related filings to US, CA, and international agencies.
Responsibilities- assemble
- format
- quality check
- publish
- archive submissions using electronic publishing tools (eCTD Manager, Adobe Acrobat, Veeva RIMS)
- ensure compliance with regional regulations
- provide regulatory guidance on documentation
- troubleshoot system issues
- and optimize submission workflows.
- minimum 1 year of regulatory electronic publishing experience
- familiarity with IND, CTA, BLA submissions
- eCTD and ESG electronic submission experience
- proficiency in MS Word and End Notes
- strong attention to detail
- analytical skills
- and ability to manage multiple tasks in a fast-paced environment.
- experience with clinical trial documentation and validation of publishing systems.
- focus on electronic publishing for regulatory submissions
- experience with global health authority filings, including IMPDs and Briefing Documents
- knowledge of regulatory compliance and document control systems.
not specified.
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