MMS

Regulatory Operations Specialist (Remote - US)

Austin, Texas, US

Role snapshot

MMS is hiring a Regulatory Operations Specialist (Remote - US) on a full-time basis. This is a remote role open to candidates in US.

Company: MMS
Location: Austin, Texas, US
Work mode: Remote
Job type: Full-time
Experience: 3+ years
Posted: Nov 6, 2026

Who this role suits

Practitioners with a few years behind them who can work independently, make trade-offs and help newer teammates.

How to prepare your application

Prepare examples of decisions you drove, how you measured the result, and how you worked with other teams.
Be ready to discuss trade-offs and scope, not only the tools you have used.
Read what MMS publishes about its product or team, so you can say clearly why this role and this company.
For remote roles, show that you communicate clearly in writing and can work without close supervision.

Apply only on MMS's own site. A genuine employer never asks candidates for money, deposits or bank details to apply, interview or “secure” a job. If something looks wrong, use Report a problem with this listing and we will review it. Read how we check listings.

About the role

Job Description

Are you looking to join a company where your contributions truly matter, and where you'll be part of a supportive, innovative team? MMS is an award-winning, data-focused clinical research organization (CRO). We pride ourselves on being a Great Place to Work® Certified organization, recognized for our exceptional culture and industry-leading employee retention. We support the pharmaceutical, biotech, and medical device industries with our proven scientific approach to complex trial data and regulatory submission challenges. With a global footprint across four continents, MMS not only maintains an industry-leading customer satisfaction rating but also fosters a collaborative and inclusive work environment where employees can thrive. Join MMS and be part of a team that is shaping the future of clinical research.

Discover more about our exciting opportunities and why MMS is a great place to advance your career. Visit www.mmsholdings.com or follow MMS on LinkedIn.

Job Specific Skills

Gains understanding of applicable regulations and ICH and health authority guidance as they pertain to document management and Regulatory Operations.
Maintaining 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.

Job Requirements

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.

Pjghmf2Vt9