Global Regulatory Submissions Specialist

MMS Holdings Inc; Denver (CO); Remote; USD 90,000 - 130,000; Full time

Job summary

MMS Holdings Inc is a data-focused clinical research organization recognized for its strong culture and award-winning workplace. This role focuses on regulatory operations, eCTD publishing, and submission readiness across health authorities.

You will maintain regulatory tracking, publish submissions, and collaborate with CROs and vendors to ensure timely, compliant regulatory documentation and project plans, while applying ISO 9001/27001 and 21 CFR Part 11 standards.

Qualifications

• Minimum 3 years in Regulatory Affairs, Regulatory Operations, or Publishing.
• College degree in a scientific/medical field; masters preferred.
• Proficiency with MS Word and Adobe Acrobat; familiarity with eCTD publishing tools.
• Understanding of ISO 9001/27001, 21 CFR Part 11, FDA, and GCP.

Responsibilities

• Publish regulatory documents per ICH eCTD standards.
• Prepare and compile documents for regulatory submissions.
• Maintain submission project plans and track timelines.
• Perform quality control on documents and submissions.

Skills

Regulatory Affairs

Regulatory Submissions

Document Publishing

Quality Control

eCTD Publishing

Coordination with CROs

Project Tracking

Education

Bachelor's degree in science/medical field

Tools

MS Office

Adobe Acrobat

eCTD Publishing Tool

SAS Viewer

IS I ToolBox

eCTD Viewer

Job description

MMS Holdings Inc is a data-focused clinical research organization recognized for its strong culture and award-winning workplace. This role focuses on regulatory operations, eCTD publishing, and submission readiness across health authorities.

You will maintain regulatory tracking, publish submissions, and collaborate with CROs and vendors to ensure timely, compliant regulatory documentation and project plans, while applying ISO 9001/27001 and 21 CFR Part 11 standards.