Regulatory Submissions & Publishing Specialist

Celldex Therapeutics, Inc.; New Haven (CT); On-site; USD 76,000 - 99,000; Full time

Job summary

Celldex Therapeutics, Inc. is seeking a Regulatory Submissions Specialist to assemble and submit regulatory filings for US and international health authorities.

You will manage paper and electronic submissions, ensure QC standards are met, and maintain submission data in RA repositories. You will collaborate with regulatory affairs to ensure publishing readiness, quality control, and on-time delivery while leveraging tools like eCTD Manager and ESG.

Qualifications

• Regulatory publishing and submission knowledge.
• Familiarity with IND/CTA/BLA submissions.
• Proficiency with publishing tools and templates.

Responsibilities

• Assemble, format, QC, publish and archive regulatory submissions to US, CA, and international health authorities using eCTD software.
• Provide regulatory guidance on quality, preclinical and clinical documentation to ensure submission readiness.
• Generate regulatory submissions on time and in compliance with company standards and regulations.
• Troubleshoot system issues as they arise and improve publishing processes.
• Archive documents per retention regulations.

Skills

Regulatory publishing

Attention to detail

Strong communication

Team collaboration

Analytical thinking

Tools

eCTD Manager

Adobe Acrobat Plug-In

Veeva RIMS

MS Word

EndNotes

Job description

Celldex Therapeutics, Inc. is seeking a Regulatory Submissions Specialist to assemble and submit regulatory filings for US and international health authorities.

You will manage paper and electronic submissions, ensure QC standards are met, and maintain submission data in RA repositories. You will collaborate with regulatory affairs to ensure publishing readiness, quality control, and on-time delivery while leveraging tools like eCTD Manager and ESG.