Regulatory Affairs Specialist (Remote - US)

MMS; Raleigh (NC); Sur place; USD 85 000 - 115 000; Plein temps

Résumé du poste

MMS is a data-focused clinical research organization seeking a Regulatory Affairs professional to support document management and submissions.

You will ensure compliance with ICH guidelines and health authority requirements, publish regulatory documents in eCTD format, and coordinate with CROs and vendors. Strong MS Office and eCTD tooling experience are essential for success.

Familiarity with ISO 9001/27001 and 21 CFR Part 11 will help ensure quality and regulatory compliance across submissions.

Qualifications

• College graduate in scientific/medical discipline or related field.
• Minimum 3 years’ experience in Regulatory Affairs or Regulatory Operations.
• Proficient with MS Office, Adobe Acrobat, and eCTD publishing tools.
• Familiar with ISO 9001/27001, 21 CFR Part 11, FDA and GCP.
• Understanding of CROs and the drug development process.

Responsabilités

• Prepare and publish regulatory submissions according to ICH eCTD format.
• Maintain tracking and archiving of submissions in document management systems.
• Conduct quality checks on documents to ensure compliance.
• Coordinate with CROs, Authorized Agents, and vendors on submissions.

Connaissances

Regulatory knowledge

eCTD publishing

Documentation management

MS Office

Adobe Acrobat

ISI ToolBox

SAS Viewer

WebTrader

Formation

Bachelor's degree in scientific field

Outils

ISI ToolBox

eCTD publishing tool

SAS Viewer

eCTD Viewer

WebTrader portals

Description du poste

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.