Global Regulatory Submissions Specialist

MMS Holdings Inc; Canton Charter Township (MI); Remote; USD 70,000 - 110,000; Full time

Job summary

MMS Holdings Inc is seeking a Regulatory Affairs Publishing professional to support submission readiness for regulatory authorities. You will manage document control, publish submissions per ICH eCTD and client guidelines, and ensure quality across documents.

You will collaborate with CROs and vendors, maintain project plans, and ensure timely delivery. A science background and experience with regulatory submissions are essential.

Qualifications

• College graduate in scientific, medical, clinical discipline or related field, or years of relevant experience, masters preferred.
• Gains understanding of MS Office and Adobe Acrobat Professional, ISI ToolBox, eCTD publishing tool, SAS Viewer, eCTD Viewer and WebTrader/ex-US portals.
• Familiarity with ISO 9001/27001 and 21 CFR Part 11.
• Knowledge of ICH guidelines and health authority submissions.
• Ability to coordinate with CROs and vendors on regulatory submissions.

Responsibilities

• Maintain regulatory tracking and archiving of submissions in document management systems.
• Publish regulatory documents and submissions according to ICH eCTD standards and client style guides.
• Prepare documents for submission to regulatory authorities.
• Perform quality control checks on documents and submissions for compliance.
• Understand eCTD structure and content of clinical study reports.
• Coordinate with CROs, local Authorized Agents, and third-party vendors.
• Maintain submission project plan and track components; manage risks and timelines.

Skills

Regulatory knowledge

Document management

eCTD publishing

Regulatory submissions

Quality control

eCTD structure

Vendor coordination

Project tracking

MS Office

Adobe Acrobat

Education

Bachelor's degree in science

Master's preferred

Tools

ISI ToolBox

eCTD publishing tool

SAS Viewer

eCTD Viewer

WebTrader/ex-US portals

Adobe Acrobat Pro

MS Office

Job description

MMS Holdings Inc is seeking a Regulatory Affairs Publishing professional to support submission readiness for regulatory authorities. You will manage document control, publish submissions per ICH eCTD and client guidelines, and ensure quality across documents.

You will collaborate with CROs and vendors, maintain project plans, and ensure timely delivery. A science background and experience with regulatory submissions are essential.