Regulatory Operations Specialist (Remote - US)
This is the employer's own posting, not a copy on a job board.
What we know
Is it still open?
Confirmed still open
Last checked 1d ago — checked against the employer's own applicant tracking system, which is the company answering directly.
We re-read the employer's own applicant tracking system and the posting was still there. That is the company answering directly.
How old is it?
Posted 27d ago
The date the source published, not the day we noticed it (2026-10-06). Last seen at its source 6h ago.
We have tracked this listing since 18 Oct 2026 (15 days). The employer's own board has carried it every time we have read it, most recently 6 hours ago.
Is it remote?
Marked remote on the employer's board
Their board carries a remote setting on this posting — a field they filled in, not wording we read. The location field names somewhere specific, which is usually where the team or the entity sits.
Who may apply?
United States
No source stated where this role may be worked. This is read from the ad's own words.
Pay not stated
Similar roles pay $106k–202.5k/yr
Middle 50% of 662 listings that do state pay — Legal & Compliance · all levels · United States · USD/year. This employer has published no salary; this is what comparable listings we hold disclose, never converted between currencies or periods. How this is calculated.
Skills named in the ad
Recognised terms only, from a fixed vocabulary — this is what CV matching compares against.
Carried by 1 source
-
JazzHR employer's own board first seen 15d ago · last seen 6h ago
- location not stated
The listing
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.
- 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.