Regulatory Affairs Specialist — Drive Submissions & Compliance

MMS; Chicago (IL); On-site; USD 90,000 - 120,000; Full time

Job summary

MMS is a data-focused clinical research organization seeking a Regulatory Operations professional to support submissions and health authority interactions in compliance with ICH guidelines.

You will maintain submission trackers, publish documents in eCTD format, perform QC checks, and coordinate with CROs, vendors, and local authorities to ensure timely regulatory deliverables. Strong MS Office and eCTD tooling experience is required.

Qualifications

• Bachelor degree or higher in a scientific/clinical field; master's preferred.
• Minimum 3 years in Regulatory Affairs/Operations or publishing.
• Proficient with MS Word/Adobe; experience with eCTD tools.
• Knowledge of ISO 9001/27001 and 21 CFR Part 11 preferred.
• Strong communication and problemsolving abilities.

Skills

Regulatory knowledge

Document management

eCTD publishing

Submission preparation

Quality control

CRO coordination

Project tracking

Communication skills

Education

Bachelor degree in scientific/medical field

Master's preferred

Tools

MS Office

Adobe Acrobat Pro

ISI ToolBox

eCTD publishing tool

SAS Viewer

eCTD Viewer

WebTrader/ex-US portals

Job description

MMS is a data-focused clinical research organization seeking a Regulatory Operations professional to support submissions and health authority interactions in compliance with ICH guidelines.

You will maintain submission trackers, publish documents in eCTD format, perform QC checks, and coordinate with CROs, vendors, and local authorities to ensure timely regulatory deliverables. Strong MS Office and eCTD tooling experience is required.