The Regulatory Operations Specialist will manage the publishing, archiving, and quality control of regulatory submissions in accordance with ICH and health authority standards. They will also coordinate with internal teams and external vendors to maintain project timelines and submission plans.
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.
Job Requirements
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.
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