Regulatory Affairs Expert - Global Submissions & Compliance

MMS Holdings Inc; Canton Charter Township (MI); Remote; USD 85,000 - 125,000; Full time

Job summary

MMS Holdings Inc., a data-focused clinical research organization with a global footprint, is seeking a Regulatory Operations professional to manage regulatory submissions and document control. You will work with ICH guidelines, prepare submission packets, and coordinate with internal teams and external vendors to ensure timely, compliant delivery.

Applicants should have 3+ years in regulatory affairs, strong MS Office and eCTD tooling skills, and a proven ability to navigate complex regulatory

Qualifications

• Requires college degree in a scientific/clinical field or equivalent experience.
• Minimum 3 years in Regulatory Affairs, Regulatory Operations, or publishing.
• Familiar with ICH guidelines and FDA/ISO standards.
• Strong communication and problem-solving skills.
• Experience with eCTD publishing and regulatory submissions.

Skills

Regulatory Operations

eCTD Publishing

Regulatory Submissions

Document Management

ISO Standards

GxP Knowledge

Communication Skills

Education

Bachelor's degree in a scientific/clinical field

Master's degree preferred

Tools

MS Office

Adobe Acrobat Pro

eCTD Tool

ISI Toolbox

SAS Viewer

WebTrader

Job description

MMS Holdings Inc., a data-focused clinical research organization with a global footprint, is seeking a Regulatory Operations professional to manage regulatory submissions and document control. You will work with ICH guidelines, prepare submission packets, and coordinate with internal teams and external vendors to ensure timely, compliant delivery.

Applicants should have 3+ years in regulatory affairs, strong MS Office and eCTD tooling skills, and a proven ability to navigate complex regulatory