Global Regulatory Affairs Specialist Submissions & Strategy

MMS Holdings Inc; Jersey City (NJ); Remote; USD 70,000 - 100,000; Full time

Job summary

MMS Holdings Inc. is a leading data-focused clinical research organization dedicated to complex trial data and regulatory submissions. The company prides itself on a Great Place to Work certification and a culture that values collaboration, inclusion, and employee development.

Join MMS to contribute to regulatory operations, publishing, and quality control in a globally oriented environment that supports pharmaceutical, biotech, and medical device industries.

Qualifications

• Gained understanding of regulations and ICH guidance related to document management and Regulatory Operations.
• Maintain regulatory tracking and archiving of submissions in document management systems.
• Publish regulatory documents per ICH eCTD format and client style guides.
• Prepare and compile documents for regulatory submissions to health authorities.
• Perform quality checks to ensure compliance with ICH and client standards.
• Understand eCTD structure and content of clinical study reports.
• Coordinate with CROs, Authorized Agents, and vendors on submissions.
• Maintain submission project plans and track components; manage risks and multiple projects.

Responsibilities

• Oversee regulatory documentation from drafting through submission.
• Ensure submission packages meet ICH and MMS standards.
• Collaborate with cross-functional teams to gather required data.
• Support project managers in timelines and risk assessments.

Skills

Regulatory affairs

Document management

eCTD publishing

Regulatory submissions

Quality control

eCTD structure

CRO coordination

Project management

Education

Bachelor's degree or higher

Tools

MS Office

Adobe Acrobat Pro

ISI ToolBox

eCTD publishing tools

SAS Viewer

eCTD Viewer/WebTrader

Job description

MMS Holdings Inc. is a leading data-focused clinical research organization dedicated to complex trial data and regulatory submissions. The company prides itself on a Great Place to Work certification and a culture that values collaboration, inclusion, and employee development.

Join MMS to contribute to regulatory operations, publishing, and quality control in a globally oriented environment that supports pharmaceutical, biotech, and medical device industries.