Global Regulatory Submissions Specialist

MMS Holdings Inc.; United States; Remote; USD 90,000 - 130,000; Full time

Job summary

MMS Holdings Inc. is a data-focused clinical research organization actively supporting regulatory submissions across global markets. We value accuracy, collaboration, and continuous improvement in a fast-paced environment.

The role focuses on regulatory operations, eCTD publishing, and coordination with health authorities, CROs, and vendors to ensure submission readiness and compliance with ICH, FDA, and client standards.

Qualifications

• College graduate in scientific, medical, clinical discipline or related field, or years of relevant experience.
• Minimum of 3 years' experience in Regulatory Affairs, Regulatory Operations, Publishing or similar field.
• Gains understanding of MS Office and Adobe Acrobat Professional, ISI ToolBox, eCTD publishing tool, SAS Viewer, eCTD Viewer and WebTrader/ex-US portals.
• Expert knowledge of scientific principles and concepts.
• Proficiency with MS Word Formatting, Adobe and other MS Office applications.
• Hands-on experience with clinical trial and pharmaceutical development preferred.
• Good communication skills and willingness to collaborate to solve problems.
• Familiarity with current ISO 9001 and ISO 27001 standards.
• Familiarity with 21 CFR Part 11, FDA, and GCP requirements.
• Understanding of CROs and scientific & clinical data/terminology, & 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 knowledge (ICH/FDA)

eCTD publishing

Regulatory submissions

Document management

Project coordination

Communication skills

Attention to detail

Education

Bachelor or higher in scientific/medical field

Masters preferred

Tools

MS Office Suite

Adobe Acrobat Pro

ISI Toolbox

eCTD publishing tool

WebTrader/ex-US portals

Job description

MMS Holdings Inc. is a data-focused clinical research organization actively supporting regulatory submissions across global markets. We value accuracy, collaboration, and continuous improvement in a fast-paced environment.

The role focuses on regulatory operations, eCTD publishing, and coordination with health authorities, CROs, and vendors to ensure submission readiness and compliance with ICH, FDA, and client standards.