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MMSRegulatory Affairs Specialist (Remote - US)
MMS, an award-winning and Great Place to Work Certified clinical research organization, seeks a Remote Regulatory Affairs Specialist to support clients in the pharmaceutical, biotech, and…
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About This Role
MMS, an award-winning and Great Place to Work Certified clinical research organization, seeks a Remote Regulatory Affairs Specialist to support clients in the pharmaceutical, biotech, and medical device sectors. This full-time position involves working remotely across the United States to handle document management, regulatory submissions, and publishing tasks within a collaborative environment. The ideal candidate will possess a background in regulatory operations or a related discipline, bringing strong problem-solving capabilities…
Job Description
MMS, an award-winning and Great Place to Work Certified clinical research organization, seeks a Remote Regulatory Affairs Specialist to support clients in the pharmaceutical, biotech, and medical device sectors. This full-time position involves working remotely across the United States to handle document management, regulatory submissions, and publishing tasks within a collaborative environment.
The ideal candidate will possess a background in regulatory operations or a related discipline, bringing strong problem-solving capabilities and communication skills to help coordinate submission projects. Responsibilities include archiving submissions, conducting quality control checks, compiling documents for health authorities, and following ICH standards.
MMS maintains a global presence across four continents and focuses on delivering scientific approaches to complex trial data and regulatory challenges. This role suits professionals seeking to advance their careers within a data-focused CRO known for industry-leading employee retention and high customer satisfaction.
Responsibilities
- Learn applicable regulations along with ICH and health authority guidance related to document management and Regulatory Operations
- Maintain regulatory tracking and handle archiving of submissions within document management systems
- Publish regulatory documents and submissions following ICH eCTD format, submission-ready standards, and client style guides
- Prepare and compile documents destined for regulatory health authorities
- Perform quality control checks on regulatory documents and submissions to guarantee compliance with ICH, MMS, and client standards
- Build familiarity with the eCTD structure and the content of clinical study reports
- Coordinate with clinical CROs, local Authorized Agents, and third-party vendors regarding regulatory submissions
- Manage submission project plans, monitor components, handle project risks and timelines, and oversee multiple projects simultaneously with guidance from a Senior ROS or Line Manager
Requirements
- Minimum of three years of direct experience in Regulatory Affairs, Regulatory Operations, Publishing, or a related area
- Expert knowledge of scientific concepts and principles
- Proficiency with Microsoft Word formatting, Adobe, and other Microsoft Office applications
- Familiarity with FDA regulations, 21 CFR Part 11, and GCP standards
- Knowledge of clinical and scientific data terminology, the drug development process, and the role of CROs
- Strong problem-solving and communication abilities to collaborate and address needs effectively
Qualifications
- College graduate holding a degree in a scientific, medical, clinical discipline, or related field (Master's degree preferred)
- Practical background in pharmaceutical development and clinical trials
- Acquaintance with ISO 9001 and ISO 27001 standards
- Familiarity with software including MS Office, Adobe Acrobat Professional, ISI ToolBox, eCTD publishing tools, SAS Viewer, eCTD Viewer, and WebTrader or ex-US portals
Core Skills
Frequently Asked Questions
Is this position remote?
Yes, this role is listed as remote within the United States.
What is the employment type for this role?
The posting indicates that this is a full-time position.
What level of experience is required?
Candidates must have a minimum of three years of experience in Regulatory Affairs, Regulatory Operations, Publishing, or a similar field.
What are the salary and benefits offered?
The source posting does not specify salary or benefit details.
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