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MMSRegulatory Operations Specialist (Remote - US)
MMS seeks a Regulatory Operations Specialist for a full-time, remote position within the United States. MMS is an award-winning clinical research organization specializing in data-focused services…
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About This Role
MMS seeks a Regulatory Operations Specialist for a full-time, remote position within the United States. MMS is an award-winning clinical research organization specializing in data-focused services for the pharmaceutical, biotech, and medical device sectors. The company is recognized as a Great Place to Work Certified organization and maintains a global footprint across four continents. The person in this role will handle document management, regulatory tracking, archiving, publishing, and quality control…
Job Description
MMS seeks a Regulatory Operations Specialist for a full-time, remote position within the United States. MMS is an award-winning clinical research organization specializing in data-focused services for the pharmaceutical, biotech, and medical device sectors. The company is recognized as a Great Place to Work Certified organization and maintains a global footprint across four continents.
The person in this role will handle document management, regulatory tracking, archiving, publishing, and quality control checks for health authority submissions. Candidates will work with electronic Common Technical Document formats, follow International Council for Harmonisation guidelines, and collaborate with clinical CROs, local authorized agents, and third-party vendors. This position suits professionals with a background in regulatory affairs or publishing who want to support clinical research trials and pharmaceutical development in a collaborative environment.
MMS complies with equal opportunity guidelines.
Responsibilities
- Maintain regulatory tracking and archive submissions within document management systems
- Publish regulatory documents and submissions following ICH eCTD formats, submission standards, and client style guides
- Prepare and compile documentation for health authority submissions
- Conduct quality control checks on regulatory submissions to ensure compliance with relevant standards
- Track components and maintain submission project plans with senior support
- Manage multiple projects simultaneously and handle project risks and timelines
Requirements
- Minimum of three years of experience in regulatory operations, regulatory affairs, publishing, or a related field
- College graduate in a scientific, medical, clinical discipline, or related field, or equivalent relevant experience
- Expert knowledge of scientific principles and concepts
- Proficiency in Microsoft Word formatting, Adobe Acrobat Professional, and other Microsoft Office applications
- Familiarity with FDA regulations, GCP requirements, and 21 CFR Part 11
- Understanding of the drug development process, CRO operations, and clinical data terminology
Qualifications
- Master degree
- Hands-on experience with pharmaceutical development and clinical trials
- Familiarity with current ISO 27001 and ISO 9001 standards
Core Skills
Frequently Asked Questions
Answers are based only on the employer’s listing; where it doesn’t say, neither do we.
Is this position remote?
Yes, this role is listed as remote within the United States.
What is the employment type?
The position is full-time.
What experience is required for this role?
Applicants must have a minimum of three years of experience in regulatory affairs, regulatory operations, publishing, or a similar field, along with a degree in a scientific, medical, or clinical discipline (or relevant experience).
What is the salary for this position?
The salary is not specified in the job posting.
Sample Interview Questions
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