Global Regulatory Submissions Specialist

MMS Holdings Inc; Chicago (IL); À distance; USD 90 000 - 120 000; Plein temps

Résumé du poste

MMS Holdings Inc. is a data-driven CRO seeking a Regulatory Operations professional to manage submission lifecycle and document control. You will publish submissions in eCTD format and ensure quality and compliance across all regulatory documents.

Ideal candidates have 3+ years in regulatory affairs, strong MS Office/Adobe skills, and familiarity with eCTD tools. Join a collaborative team supporting pharma, biotech, and device clients across a global footprint.

Qualifications

• College degree or equivalent experience in a scientific/clinical field.
• 3+ years in Regulatory Affairs/Regulatory Operations or publishing.
• Proficiency with MS Office and Acrobat; familiarity with eCTD publishing tools.

Responsabilités

• Maintain regulatory submission tracking and archiving.
• Publish regulatory documents in eCTD format according to guidelines.
• Prepare documents for regulatory submissions to authorities.
• Perform quality checks on submissions to ensure compliance with standards.

Connaissances

Regulatory operations

Documentation management

eCTD publishing

Regulatory submissions

Quality control

CRO/regulatory knowledge

Formation

Bachelor's or higher in scientific field

Outils

MS Office

Adobe Acrobat Pro

ISI ToolBox

eCTD publishing tool

SAS Viewer

eCTD Viewer

WebTrader/ex-US portals

Description du poste

MMS Holdings Inc. is a data-driven CRO seeking a Regulatory Operations professional to manage submission lifecycle and document control. You will publish submissions in eCTD format and ensure quality and compliance across all regulatory documents.

Ideal candidates have 3+ years in regulatory affairs, strong MS Office/Adobe skills, and familiarity with eCTD tools. Join a collaborative team supporting pharma, biotech, and device clients across a global footprint.