Regulatory Affairs Specialist

Job overview

The Regulatory Affairs Specialist role is described as remote in the United States; compensation is not specified. MMS is a clinical research organization supporting pharmaceutical, biotech, and medical device industries with trial data and regulatory submission work. The specialist prepares, publishes, tracks, and quality-checks regulatory submissions so documents meet applicable guidance and client standards. Project tracking and coordination support timely, compliant submissions across multiple projects.

What you'll do

• Maintain regulatory tracking and archive submissions in document management systems
• publish regulatory documents and submissions in ICH eCTD format and according to submission-ready standards and client style guides
• prepare and compile documents for health authority submissions
• perform quality control checks
• coordinate with clinical CROs, local Authorized Agents, and third-party vendors with support
• maintain project plans, track components, manage risks and timelines, and handle multiple projects with support.

What we're looking for

Skills & competencies

regulatory affairs specialist

remote us

mms

full-time

regulatory operations

ectd publishing

ich guidance

health authority submissions

document management

quality control

clinical research

fda and gcp

Work arrangement

• Weekend coverage required

Why this role

The posting identifies MMS as an award-winning, data-focused clinical research organization with a global footprint; the listing title specifies remote US, while the XML also describes hybrid remote.

About the employer

MMS is hiring for this role. Industry: Research and Development in Biotechnology (except Nanobiotechnology). Sector: 54.