Global Regulatory Submissions Specialist (eCTD Expert)

Scorpion Therapeutics; New Haven (CT); On-site; USD 80,000 - 120,000; Full time

Job summary

Scorpion Therapeutics is seeking a Regulatory Submissions Specialist to prepare, process, and submit regulatory documentation for IND, CTA, BLA, and related filings to US, CA, and international agencies.

The role focuses on electronic publishing, quality checks, and publishing workflows using eCTD Manager, Adobe Acrobat, and Veeva RIMS, ensuring compliance with regional regulations while supporting global submissions.

Qualifications

• Experience in regulatory submissions and electronic publishing for IND/CTA/BLA filings.
• Familiarity with eCTD format and ESG submission standards.
• Proficiency in MS Word and EndNote for document preparation.

Responsibilities

• Assemble regulatory submissions and format documents.
• Quality check and publish submissions using publishing tools.
• Archive submissions and ensure regulatory compliance across regions.
• Provide regulatory guidance on documentation and troubleshoot system issues.

Skills

Regulatory submissions

Electronic publishing

Attention to detail

Analytical skills

Multitasking

Tools

MS Word

EndNote

eCTD ESG submission tools

Job description

Scorpion Therapeutics is seeking a Regulatory Submissions Specialist to prepare, process, and submit regulatory documentation for IND, CTA, BLA, and related filings to US, CA, and international agencies.

The role focuses on electronic publishing, quality checks, and publishing workflows using eCTD Manager, Adobe Acrobat, and Veeva RIMS, ensuring compliance with regional regulations while supporting global submissions.