Regulatory Submissions & eCTD Specialist

MMS Holdings Inc; Jersey City (NJ); Remote; USD 90,000 - 120,000; Full time

Job summary

MMS Holdings Inc is seeking a regulatory operations professional to manage document control, publishing, and submission readiness. The role requires strong ICH eCTD experience, familiarity with FDA and GCP requirements, and collaboration with CROs and vendors.

The candidate should have 3+ years in regulatory affairs or a related field, with proficiency in MS Office, Adobe Acrobat, and eCTD tools, to ensure timely, compliant submissions across projects.

Qualifications

• Bachelor’s or higher in a scientific/clinical field, or equivalent experience.
• 3+ years in Regulatory Affairs, Regulatory Operations, Publishing or related field.
• Experience with MS Office, Adobe Acrobat, ISI Toolbox, and eCTD publishing tools.
• Solid understanding of ICH guidelines and FDA/GxP requirements.
• Experience with regulatory submissions and document management systems.

Responsibilities

• Maintain regulatory submission tracking and archiving in document management systems.
• Publish regulatory documents and submissions per ICH-eCTD and client style guides.
• Prepare and compile documents for regulatory submissions to health authorities.
• Perform quality control checks on documents and submissions for compliance.
• Understand eCTD structure and clinical study reports; coordinate with CROs and vendors.

Skills

Regulatory knowledge

Document management

Quality control

Communication

Problem solving

Team coordination

Education

College graduate in scientific/medical/clinical discipline or related field, or years of relevant experience, masters preferred

Tools

MS Office

Adobe Acrobat Pro

ISI Toolbox

eCTD publishing tool

SAS Viewer

eCTD Viewer

WebTrader/ex-US portals

Job description

MMS Holdings Inc is seeking a regulatory operations professional to manage document control, publishing, and submission readiness. The role requires strong ICH eCTD experience, familiarity with FDA and GCP requirements, and collaboration with CROs and vendors.

The candidate should have 3+ years in regulatory affairs or a related field, with proficiency in MS Office, Adobe Acrobat, and eCTD tools, to ensure timely, compliant submissions across projects.