Global Regulatory Submissions Specialist

MMS Holdings Inc; Chicago (IL); Remote; USD 85,000 - 115,000; Full time

Job summary

MMS Holdings Inc. in Chicago seeks a Regulatory Operations professional to manage document submissions and publishing in alignment with ICH eCTD standards.

You will coordinate with CROs, vendors, and health authorities to ensure timely, compliant regulatory submissions. Ideal candidates have 3+ years in Regulatory Affairs or Publishing, strong MS Office and eCTD tooling skills, and a solid understanding of 21 CFR Part 11 and FDA guidelines.

Qualifications

• College graduate in scientific, medical, clinical discipline or related field, or years of relevant experience, masters preferred.
• Minimum of 3 years’ experience in Regulatory Affairs, Regulatory Operations, Publishing or similar field required.
• Gains understanding of MS Office and Adobe Acrobat Professional, ISI ToolBox, eCTD publishing tool, SAS Viewer, eCTD Viewer and WebTrader/ex-US portals.
• Familiar with ISO 9001 and ISO 27001 standards.
• Familiarity with 21 CFR Part 11, FDA, and GCP requirements.
• Understanding of CROs and scientific & clinical data/terminology, and the drug development process.

Responsibilities

• Maintain regulatory tracking and archiving of submissions in document management systems.
• Publishing regulatory documents and submissions according to ICH eCTD format, submission ready standards and client style guides.
• Preparing and compiling documents for submission to regulatory health authorities.
• Perform quality control checks to documents and regulatory submissions to ensure compliance with ICH and MMS and client standards.
• Gains understanding of the eCTD structure and the structure and content of clinical study reports.
• Gains understanding of simple coordination with clinical CROs, local Authorized Agents and third-party vendors on regulatory submissions.
• With support from Sr ROS or LM: Maintain submission project plan and track components; Manage project risks and timeline; Manage multiple projects simultaneously.

Skills

Regulatory submissions process

Document management

ICH eCTD publishing

Regulatory operations coordination

Quality control checks

Regulatory guidelines (FDA, GxP)

Team collaboration

SAS Viewer / ISI Toolbox

Education

College graduate in scientific/medical/clinical discipline

Masters preferred

Tools

MS Office

Adobe Acrobat Professional

ISI ToolBox

eCTD publishing tool

SAS Viewer

eCTD Viewer

WebTrader/ex-US portals

Job description

MMS Holdings Inc. in Chicago seeks a Regulatory Operations professional to manage document submissions and publishing in alignment with ICH eCTD standards.

You will coordinate with CROs, vendors, and health authorities to ensure timely, compliant regulatory submissions. Ideal candidates have 3+ years in Regulatory Affairs or Publishing, strong MS Office and eCTD tooling skills, and a solid understanding of 21 CFR Part 11 and FDA guidelines.