Regulatory Affairs Specialist: Submissions & Compliance

MMS; Raleigh (NC); On-site; USD 85,000 - 115,000; Full time

Job summary

MMS is a data-focused clinical research organization seeking a Regulatory Affairs professional to support document management and submissions.

You will ensure compliance with ICH guidelines and health authority requirements, publish regulatory documents in eCTD format, and coordinate with CROs and vendors. Strong MS Office and eCTD tooling experience are essential for success.

Familiarity with ISO 9001/27001 and 21 CFR Part 11 will help ensure quality and regulatory compliance across submissions.

Qualifications

• College graduate in scientific/medical discipline or related field.
• Minimum 3 years’ experience in Regulatory Affairs or Regulatory Operations.
• Proficient with MS Office, Adobe Acrobat, and eCTD publishing tools.
• Familiar with ISO 9001/27001, 21 CFR Part 11, FDA and GCP.
• Understanding of CROs and the drug development process.

Responsibilities

• Prepare and publish regulatory submissions according to ICH eCTD format.
• Maintain tracking and archiving of submissions in document management systems.
• Conduct quality checks on documents to ensure compliance.
• Coordinate with CROs, Authorized Agents, and vendors on submissions.

Skills

Regulatory knowledge

eCTD publishing

Documentation management

MS Office

Adobe Acrobat

ISI ToolBox

SAS Viewer

WebTrader

Education

Bachelor's degree in scientific field

Tools

ISI ToolBox

eCTD publishing tool

SAS Viewer

eCTD Viewer

WebTrader portals

Job description

MMS is a data-focused clinical research organization seeking a Regulatory Affairs professional to support document management and submissions.

You will ensure compliance with ICH guidelines and health authority requirements, publish regulatory documents in eCTD format, and coordinate with CROs and vendors. Strong MS Office and eCTD tooling experience are essential for success.

Familiarity with ISO 9001/27001 and 21 CFR Part 11 will help ensure quality and regulatory compliance across submissions.