Regulatory Affairs Specialist (Remote US)

Are you looking to join a company where your contributions truly matter and where youll 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 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 clientstandards.
• 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.