Regulatory Affairs Specialist: Submissions & eCTD Expert

MMS; Phoenix (AZ); On-site; USD 90,000 - 120,000; Full time

Job summary

MMS Holdings is a data-focused clinical research organization (CRO) seeking a Regulatory Operations professional to manage regulatory documents, submissions, and tracking in line with ICH and client standards.

The role requires collaboration with clinical teams and vendors, ensuring submission readiness and timely QC checks. Proficiency with eCTD formats and regulatory tools is essential for success.

Qualifications

• Minimum 3 years’ experience in Regulatory Affairs or related field.
• Bachelor’s or higher in science; Master’s preferred.
• Proficiency with MS Word/Office and Adobe Acrobat.
• Experience with regulatory submissions to health authorities.
• Familiarity with ISO 9001 and ISO 27001 standards preferred.
• Knowledge of 21 CFR Part 11, FDA, and GCP requirements.

Skills

Regulatory knowledge

Regulatory tracking

eCTD publishing

Document preparation

Quality control

eCTD structure

Vendor coordination

Project planning

Education

Bachelor’s or higher in science

Master’s preferred

Tools

MS Office

Adobe Acrobat

ISI ToolBox

eCTD publishing tool

SAS Viewer

eCTD Viewer

WebTrader

Job description

MMS Holdings is a data-focused clinical research organization (CRO) seeking a Regulatory Operations professional to manage regulatory documents, submissions, and tracking in line with ICH and client standards.

The role requires collaboration with clinical teams and vendors, ensuring submission readiness and timely QC checks. Proficiency with eCTD formats and regulatory tools is essential for success.