Regulatory Submissions Specialist - eCTD & Filing Expert

Celldex; New Haven (CT); On-site; USD 76,374 - 99,188; Full time

Benefits offered by this job

Health insurance

401(k) plan

Paid holidays

Vacation & sick days

Bonus program

Job summary

Celldex is seeking a Regulatory Submissions Specialist to compile and submit regulatory documents (IND, CTA, BLA) to the US, Canada and other authorities, using eCTD publishing software. You will work with regulatory staff to ensure submission readiness, quality control, and on-time dispatch.

The role requires experience with electronic submissions, ESG gateways, Veeva RIMS, and strong proofreading abilities.

Qualifications

• Minimum of 1 year regulatory affairs electronic publishing experience preferred; other relevant experience with clinical trial documentation and electronic systems will be considered.
• Experience with IND, CTA, BLA submissions.
• eCTD paperless submission experience using agency electronic submission’s gateway (ESG).
• Experience preparing and submitting regulatory filings using Veeva RIMS.
• Proficient in MS Word formatting large documents and using templates.
• EndNotes software experience a plus.

Responsibilities

• Work with regulatory staff to prepare, assemble, process, format, quality control, publish, submit and archive submissions to US, CA and other international health authorities using advanced electronic publishing software for electronic, paper or hybrid submissions.
• Provide regulatory guidance on quality, preclinical and clinical documentation to ensure submission readiness and compliance.
• Generate regulatory submissions on time and in compliance with Company standards and regional regulatory agency regulations.
• Assist with troubleshooting system issues.
• Assist with developing best practices in submission publishing and enhancing process efficiency.
• Archive documents according to archiving and document retention regulations.

Skills

Regulatory submissions

Electronic publishing

eCTD

Veeva RIMS

Quality control

Attention to detail

Tools

eCTD Manager

Adobe Acrobat

ESG gateway

EndNotes

MS Word

Veeva RIMS

Job description

Celldex is seeking a Regulatory Submissions Specialist to compile and submit regulatory documents (IND, CTA, BLA) to the US, Canada and other authorities, using eCTD publishing software. You will work with regulatory staff to ensure submission readiness, quality control, and on-time dispatch.

The role requires experience with electronic submissions, ESG gateways, Veeva RIMS, and strong proofreading abilities.