Regulatory Affairs Specialist (Remote - US)

MMS; Canton Charter Township (MI); On-site; USD 90,000 - 130,000; Full time

Job summary

MMS, a data-focused clinical research organization, seeks a Regulatory Operations/Publishing professional to manage submission publishing, tracking, and compliance with ICH, FDA, and client standards. Candidates should have 3+ years in regulatory roles and strong MS Office/Adobe tool experience.

The role involves coordinating with CROs and vendors, maintaining eCTD structures, and ensuring timetables and quality controls for regulatory submissions across global programs.

Qualifications

• 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.

Skills

Regulatory knowledge (ICH/FDA)

Regulatory submissions

Document publishing

Submission planning

Quality control

eCTD structure

Coordination with CROs/agents

Project tracking & risk management

Education

College degree in scientific/medical/clinical field

Master's degree preferred

Tools

MS Office

Adobe Acrobat Pro

ISI ToolBox

eCTD publishing tool

SAS Viewer

eCTD Viewer

WebTrader/ex-US portals

Job description

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.