Regulatory Affairs Specialist (Remote - US)
Are you looking to join a company where your contributions truly matter, and where you'll be part of a supportive, innovative team? MMS is an award-winning, data-focused clinical research organization (CRO). We pride ourselves on being a Great Place to Work® Certified organization, recognized for our exceptional culture and industry-leading employee retention. We support the pharmaceutical, biotech, and medical device industries with our proven scientific approach to complex trial data and regulatory submission challenges. With a global footprint across four continents, MMS not only maintains an industry-leading customer satisfaction rating but also fosters a collaborative and inclusive work environment where employees can thrive. Join MMS and be part of a team that is shaping the future of clinical research.
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.
College degree in a scientific, medical, or clinical field or relevant experience; 3+ years in regulatory affairs, operations, publishing, or similar; proficiency with regulatory software and MS Office; knowledge of ICH, FDA, GCP, and eCTD.
Key Responsibilities
- publishing submissions
- compiling documents
- tracking submissions
Skills & Tools
Microsoft Office, Adobe Acrobat Professional, ISI ToolBox, SAS Viewer, eCTD Viewer, WebTrader, Microsoft Word, Adobe Acrobat, eCTD
Job Details
- Category: Legal and Compliance
- Seniority: Mid Level
- Commitment: Full Time
- Workplace: Remote — United States
- Languages: English
About MMS Holdings
An award-winning clinical research organization supporting pharmaceutical, biotech, and medical device companies with clinical trial data and regulatory submissions. — Industry: Research and Development