Regulatory Affairs Specialist | Remote, US

Job overview

The Regulatory Affairs Specialist | Remote, US is listed as remote in the United States; the listing location is Aurora, CO. Compensation is not specified. MMS is a clinical research organization supporting pharmaceutical, biotech, and medical device companies with clinical trial data and regulatory submission work.

What you'll do

• Maintain regulatory submission tracking and archiving
• publish regulatory documents in 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, authorized agents, and vendors
• with senior support, maintain project plans, track components, risks, and timelines, and manage multiple projects.

What we're looking for

Skills & competencies

full-time

remote us

mms

regulatory affairs

regulatory operations

ectd publishing

health authority submissions

clinical research

document quality control

pharmaceutical

biotech

medical devices

Work arrangement

• Weekend coverage required

Why this role

Requires at least three years of experience in Regulatory Affairs, Regulatory Operations, Publishing, or a similar field; scientific, medical, or clinical education or relevant experience; familiarity with FDA, GCP, and 21 CFR Part 11 requirements.

About the employer

MMS is hiring for this role. Industry: Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology). Sector: 54.