Remote eCTD Submissions Specialist

Pharmaceutical Company; Branchburg Township (NJ); Remote; USD 90,000 - 120,000; Full time

Benefits offered by this job

Remote work

Job summary

Pharmaceutical Company seeks an experienced Regulatory Submission Publishing Specialist to support its Diagnostics Regulatory Affairs team. You will manage preparation, publishing, quality review, and electronic submission of regulatory dossiers for global diagnostic products, leveraging eCTD publishing expertise.

Responsibilities include preparing and submitting FDA/EMA dossiers (510(k), PMA, BLA, IND, IVDR), using Veeva Vault, LORENZ docuBridge FIVE, or eCTD Xpress, and coordinating with

Qualifications

• Bachelor's degree in Life Sciences, Regulatory Science, QA, or related field; advanced degree preferred.
• 5+ years in regulatory submission publishing within diagnostics or life sciences.
• Strong understanding of FDA, EMA, and ICH regulatory requirements.
• Hands-on experience with eCTD publishing, dossier compilation, validation, and submission quality control.
• Experience with regulatory publishing platforms such as Veeva Vault, LORENZ docuBridge FIVE, or eCTD Xpress.
• Familiarity with electronic submission gateways and global regulatory submission processes.
• Excellent organizational, communication, and stakeholder management skills.

Responsibilities

• Prepare, publish, validate, and submit regulatory dossiers for diagnostic products across global markets.
• Support regulatory submissions including FDA 510(k), PMA, BLA, IND, IDE, IVDR, and other types.
• Use platforms such as Veeva Vault, LORENZ docuBridge FIVE, or eCTD Xpress to compile and validate submissions.
• Manage electronic submissions through FDA CCP/ESG, EMA Gateway, and Notified Body portals.
• Perform quality checks, review validation reports, resolve publishing errors, ensure accuracy.
• Manage submission sequences, timelines, document traceability, and archiving.
• Maintain regulatory document repositories using Veeva Vault, Veeva RIM, DMS, and CMS.
• Collaborate with Regulatory Affairs, Quality, IT, and vendors to resolve issues and meet deadlines.
• Support publishing automation initiatives and emerging technologies (AI, RPA).

Skills

eCTD publishing

FDA/EMA knowledge

Regulatory submissions experience

Veeva Vault

LORENZ docuBridge FIVE

Automation tools (AI/RPA)

Education

Bachelor's degree in Life Sciences or Regulatory Science

Tools

Veeva Vault

LORENZ docuBridge FIVE

eCTD Xpress

DMS

CMS

Job description

Pharmaceutical Company seeks an experienced Regulatory Submission Publishing Specialist to support its Diagnostics Regulatory Affairs team. You will manage preparation, publishing, quality review, and electronic submission of regulatory dossiers for global diagnostic products, leveraging eCTD publishing expertise.

Responsibilities include preparing and submitting FDA/EMA dossiers (510(k), PMA, BLA, IND, IVDR), using Veeva Vault, LORENZ docuBridge FIVE, or eCTD Xpress, and coordinating with