Global Regulatory Affairs Specialist — Data-Driven CRO

MMS Holdings Inc; Denver (CO); Remote; USD 70,000 - 100,000; Full time

Job summary

MMS Holdings Inc in Denver seeks a Regulatory Operations professional to manage document publishing and regulatory submissions. The role requires meticulous attention to ICH guidelines and client standards, with focus on eCTD compliance and archiving in a controlled document system.

You will coordinate with CROs and vendors, track project plans, and monitor risks across multiple submissions, ensuring timely delivery and regulatory readiness for health authorities.

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.
• 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

• Publish regulatory documents and submissions according to ICH eCTD format, submission ready standards and client style guides.
• Maintain regulatory tracking and archiving of submissions in document management systems.
• Gains understanding of the eCTD structure and the structure and content of clinical study reports.
• Prepare and compile 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.
• Coordinate with clinical CROs, local Authorized Agents and third-party vendors on regulatory submissions.
• Maintain submission project plan and track components; Manage project risks and timeline; Manage multiple projects simultaneously.

Skills

Regulatory knowledge

Documentation control

Regulatory submissions

Communication

Problem solving

ISO 9001 familiarity

Education

Masters preferred

College degree in scientific/medical/clinical field

Tools

MS Office

Adobe Acrobat

eCTD publishing tool

SAS Viewer

ISI Toolbox

WebTrader/ex-US portals

Job description

MMS Holdings Inc in Denver seeks a Regulatory Operations professional to manage document publishing and regulatory submissions. The role requires meticulous attention to ICH guidelines and client standards, with focus on eCTD compliance and archiving in a controlled document system.

You will coordinate with CROs and vendors, track project plans, and monitor risks across multiple submissions, ensuring timely delivery and regulatory readiness for health authorities.