Regulatory Submissions Specialist – ICH eCTD & Compliance

MMS Holdings Inc; Austin (TX); Remote; USD 85,000 - 125,000; Full time

Job summary

MMS Holdings Inc. is seeking a Regulatory Operations professional in Austin to manage regulatory submissions and document control.

The role requires familiarity with ICH eCTD standards, FDA requirements, and ISO guidelines, with collaboration across CROs and vendors to ensure timely submissions. Ideal candidates will have at least 3 years in regulatory affairs, strong MS Office skills, and experience with eCTD publishing tools.

Qualifications

• College graduate in scientific, medical, clinical discipline or related field, or years of relevant experience, masters preferred.
• Minimum of 3 years’ experience in Regulatory Affairs, Regulatory Operations, Publishing or similar field required.
• Gains understanding of MS Office and Adobe Acrobat Professional, ISI ToolBox, eCTD publishing tool, SAS Viewer, eCTD Viewer and WebTrader/ex-US portals.
• Expert knowledge of scientific principles and concepts.
• Proficiency with MS Word Formatting, Adobe and other MS Office applications.
• Hands-on experience with clinical trial and pharmaceutical development preferred.
• Good communication skills and willingness to work with others to clearly understand needs and solve problems.
• Excellent problem-solving skills.
• Familiarity with current ISO 9001 and ISO 27001 standards preferred.
• Familiarity with 21 CFR Part 11, FDA, and GCP requirements.
• Understanding of CROs and scientific & clinical data/terminology, & the drug development process.

Responsibilities

• Maintain regulatory tracking and archiving of submissions in document management systems.
• Publishing regulatory documents and submissions according to ICH eCTD format, submission ready standards and client style guides.
• Preparing and compiling documents for submission to regulatory health authorities.
• Perform quality control checks to documents and regulatory submissions to ensure compliance with ICH and MMS and client standards.
• Gains understanding of the eCTD structure and the structure and content of clinical study reports.
• Gains understanding of simple coordination with clinical CROs, local Authorized Agents and third-party vendors on regulatory submissions.
• With support from Sr ROS or LM: Maintain submission project plan and track components; Manage project risks and timeline; Manage multiple projects simultaneously.

Skills

Regulatory knowledge

Documentation management

Communication skills

Problem solving

Team collaboration

Education

College degree in scientific/medical/clinical field

Masters preferred

Tools

MS Office

Adobe Acrobat Pro

ISIToolBox

eCTD publishing tool

SAS Viewer

WebTrader/ex-US portals

Job description

MMS Holdings Inc. is seeking a Regulatory Operations professional in Austin to manage regulatory submissions and document control.

The role requires familiarity with ICH eCTD standards, FDA requirements, and ISO guidelines, with collaboration across CROs and vendors to ensure timely submissions. Ideal candidates will have at least 3 years in regulatory affairs, strong MS Office skills, and experience with eCTD publishing tools.