Global Regulatory Submissions Specialist (eCTD & ICH)

MMS; Denver (CO); On-site; USD 85,000 - 130,000; Full time

Job summary

MMS, a data-focused clinical research organization, is seeking a Regulatory Operations professional to support publishing and submissions in accordance with ICH/eCTD standards. The role requires coordination with CROs and vendors, ensuring compliance with regulatory guidelines, and maintaining submission readiness across projects.

Applicants should have strong MS Office and Adobe Acrobat skills, plus familiarity with eCTD tools and regulatory submission processes.

Qualifications

• Bachelor's degree in a scientific or related field is required or equivalent experience.
• Minimum 3 years' experience in Regulatory Affairs or related field.
• Strong knowledge of ICH, FDA, and GxP regulations.
• Experience with document management systems and regulatory submissions.
• Proficiency with MS Office and Adobe Acrobat.

Skills

Regulatory guidance

Regulatory tracking

eCTD publishing

Document management

Regulatory publishing

Quality control of submissions

eCTD structure

Vendor coordination

Project planning

MS Office

Adobe Acrobat

SAS Viewer

Education

Bachelor's degree in scientific field

Master's degree preferred

Tools

ISI ToolBox

SAS Viewer

eCTD publishing tool

WebTrader

Job description

MMS, a data-focused clinical research organization, is seeking a Regulatory Operations professional to support publishing and submissions in accordance with ICH/eCTD standards. The role requires coordination with CROs and vendors, ensuring compliance with regulatory guidelines, and maintaining submission readiness across projects.

Applicants should have strong MS Office and Adobe Acrobat skills, plus familiarity with eCTD tools and regulatory submission processes.