Regulatory Submissions Specialist — ICH/eCTD Expert

MMS; Jersey City (NJ); On-site; USD 70,000 - 110,000; Full time

Job summary

MMS is seeking a Regulatory Operations professional to manage document publishing and submissions for regulatory authorities. You will ensure accuracy, compliance, and timely delivery of submission packages across ICH guidelines and client standards.

The role requires experience with eCTD formats, document management, and collaboration with CROs and internal teams to meet timelines and quality expectations.

Qualifications

• College graduate or higher in scientific/clinical field; or equivalent experience.

Responsibilities

• Understand regulatory requirements and ICH/health authority guidance for submissions.
• Publish regulatory documents to eCTD format and ensure submission readiness according to client style guides.
• Prepare, compile and submit documents to regulatory authorities.
• Perform quality control checks on documents to ensure compliance with ICH, MMS and client standards.
• Maintain submission project plans and track components; manage risks and timelines.

Skills

Regulatory knowledge

Document management

eCTD publishing

Submission preparation

Quality checks

eCTD structure

Vendor coordination

Project management

Education

Bachelor's degree or higher

Tools

MS Office

Adobe Acrobat Pro

ISI Toolbox

eCTD publishing tool

SAS Viewer

eCTD Viewer

WebTrader/ex-US portals

Job description

MMS is seeking a Regulatory Operations professional to manage document publishing and submissions for regulatory authorities. You will ensure accuracy, compliance, and timely delivery of submission packages across ICH guidelines and client standards.

The role requires experience with eCTD formats, document management, and collaboration with CROs and internal teams to meet timelines and quality expectations.