Regulatory Affairs Specialist: Elevate Submissions

MMS Holdings Inc; Phoenix (AZ); Remote; USD 90,000 - 130,000; Full time

Job summary

MMS Holdings Inc is seeking a qualified Regulatory Operations professional to join our data-focused CRO team in the United States. You will manage regulatory documents, publish submissions in eCTD format, and ensure quality control across regulatory packages for health authorities.

The role requires a college degree in science, 3+ years in regulatory affairs/publishing, and strong MS Office/Adobe Acrobat skills. ISO/GxP familiarity and coordination with CROs are preferred.

Qualifications

• Bachelor's or higher in scientific/medical field; relevant experience accepted.
• Min 3 years in Regulatory Affairs or Publishing or related area.
• Strong MS Office and Adobe Acrobat skills; familiarity with eCTD publishing.
• Understanding of ICH, FDA, and GxP guidelines is preferred.
• Experience with regulatory submissions and health authority interactions is advantageous.

Responsibilities

• Understand regulations and ICH guidance as they apply to document management.
• Maintain regulatory tracking and archiving in DMS.
• Publish regulatory documents per ICH eCTD standards and client style guides.
• Prepare and compile submissions for health authorities.
• Perform QC on documents and regulatory submissions for compliance.
• Understand eCTD structure and contents of clinical study reports.
• Coordinate with CROs, agents, and vendors on submissions as needed.
• With support from senior ROS/LM: track project plans, risks, and timelines.

Skills

Regulatory affairs

Regulatory operations

Publishing

Document management

eCTD submissions

Quality control

Project coordination

MS Office

Adobe Acrobat Pro

ISIToolBox

SAS Viewer

Education

College degree in scientific field

Masters preferred

Tools

eCTD publishing tool

ISI ToolBox

WebTrader ex-US portals

SAS Viewer

Adobe Acrobat Pro

MS Word

Job description

MMS Holdings Inc is seeking a qualified Regulatory Operations professional to join our data-focused CRO team in the United States. You will manage regulatory documents, publish submissions in eCTD format, and ensure quality control across regulatory packages for health authorities.

The role requires a college degree in science, 3+ years in regulatory affairs/publishing, and strong MS Office/Adobe Acrobat skills. ISO/GxP familiarity and coordination with CROs are preferred.