Regulatory Submissions Specialist — Global Clinical Research

MMS Holdings Inc; Raleigh (NC); Remote; USD 70,000 - 110,000; Full time

Job summary

MMS Holdings Inc is seeking a Regulatory Affairs professional in the United States to join a data-focused CRO team. You will manage regulatory tracking, publish eCTD submissions, and coordinate with CROs, agents and vendors to ensure timely, compliant submissions.

The role requires at least 3 years in Regulatory Affairs or related fields, strong MS Office and eCTD skills, and familiarity with FDA, GCP and ISO standards.

Qualifications

• College degree in science or related field; relevant experience; masters preferred.
• Minimum 3 years in Regulatory Affairs or Regulatory Operations.
• Proficiency with MS Office, Adobe Acrobat, ISI Toolbox, eCTD tools, SAS Viewer, WebTrader.
• Expert knowledge of scientific principles.
• Strong MS Word formatting and MS Office skills.
• Experience with clinical trials/pharma development preferred.
• Good communication and problem-solving skills.
• Excellent problem-solving abilities.
• Familiarity with ISO 9001 and ISO 27001.
• Familiarity with 21 CFR Part 11, FDA and GCP.
• Understanding of CROs and drug development process.

Responsibilities

• Maintain regulatory tracking and submission archiving.
• Publish regulatory documents per ICH eCTD and client standards.
• Prepare and compile submissions for regulatory authorities.
• QC documents to ensure ICH/MMS and client standards.
• Understand eCTD structure and clinical study reports.
• Coordinate with CROs, local Authorized Agents and vendors on submissions.
• Maintain submission project plans and track components; manage risks and timelines; manage multiple projects.

Skills

Regulatory knowledge

Document management

eCTD publishing

Regulatory submissions

Quality control

CRO coordination

Project tracking

Risk management

Education

Bachelor's degree in science

Master's degree preferred

Tools

MS Office

Adobe Acrobat

ISI Toolbox

eCTD publishing tool

SAS Viewer

eCTD Viewer

WebTrader/ex-US portals

Job description

MMS Holdings Inc is seeking a Regulatory Affairs professional in the United States to join a data-focused CRO team. You will manage regulatory tracking, publish eCTD submissions, and coordinate with CROs, agents and vendors to ensure timely, compliant submissions.

The role requires at least 3 years in Regulatory Affairs or related fields, strong MS Office and eCTD skills, and familiarity with FDA, GCP and ISO standards.