Global Regulatory Submissions Specialist

MMS Holdings Inc; Northern (KY); Remote; USD 85,000 - 115,000; Full time

Job summary

MMS Holdings Inc is seeking a regulatory operations professional to support document management, submissions, and regulatory lifecycle activities in a CRO environment.

The role requires 3+ years in regulatory affairs, strong MS Office and eCTD tooling, and ability to coordinate with CROs and authorities. Join a data-driven team focused on quality and compliance in the drug development process.

Qualifications

• Bachelor's degree in scientific or medical field or equivalent experience; master's preferred.
• Minimum of 3 years in Regulatory Affairs, Regulatory Operations, Publishing or similar.
• Knowledge of MS Office, Adobe Acrobat and eCTD publishing tools.
• Familiarity with ISO 9001 and ISO 27001; 21 CFR Part 11, FDA and GCP.
• Understanding of CROs and the drug development process.

Responsibilities

• Gains understanding of applicable regulations and ICH and health authority guidance as they pertain to document management and Regulatory Operations.
• Maintaining 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

eCTD publishing

MS Office

Adobe Acrobat

Communication

Problem-solving

Education

Bachelor's in scientific/medical field

Masters preferred

Tools

eCTD publishing tool

SAS Viewer

ISI ToolBox

eCTD Viewer

WebTrader/ex-US portals

Job description

MMS Holdings Inc is seeking a regulatory operations professional to support document management, submissions, and regulatory lifecycle activities in a CRO environment.

The role requires 3+ years in regulatory affairs, strong MS Office and eCTD tooling, and ability to coordinate with CROs and authorities. Join a data-driven team focused on quality and compliance in the drug development process.