Regulatory Affairs Specialist (Remote - US)

MMS Holdings Inc; Phoenix (AZ); Remote; USD 90,000 - 130,000; Full time

Job summary

MMS Holdings Inc is seeking a qualified Regulatory Operations professional to join our data-focused CRO team in the United States. You will manage regulatory documents, publish submissions in eCTD format, and ensure quality control across regulatory packages for health authorities.

The role requires a college degree in science, 3+ years in regulatory affairs/publishing, and strong MS Office/Adobe Acrobat skills. ISO/GxP familiarity and coordination with CROs are preferred.

Qualifications

• Bachelor's or higher in scientific/medical field; relevant experience accepted.
• Min 3 years in Regulatory Affairs or Publishing or related area.
• Strong MS Office and Adobe Acrobat skills; familiarity with eCTD publishing.
• Understanding of ICH, FDA, and GxP guidelines is preferred.
• Experience with regulatory submissions and health authority interactions is advantageous.

Responsibilities

• Understand regulations and ICH guidance as they apply to document management.
• Maintain regulatory tracking and archiving in DMS.
• Publish regulatory documents per ICH eCTD standards and client style guides.
• Prepare and compile submissions for health authorities.
• Perform QC on documents and regulatory submissions for compliance.
• Understand eCTD structure and contents of clinical study reports.
• Coordinate with CROs, agents, and vendors on submissions as needed.
• With support from senior ROS/LM: track project plans, risks, and timelines.

Skills

Regulatory affairs

Regulatory operations

Publishing

Document management

eCTD submissions

Quality control

Project coordination

MS Office

Adobe Acrobat Pro

ISIToolBox

SAS Viewer

Education

College degree in scientific field

Masters preferred

Tools

eCTD publishing tool

ISI ToolBox

WebTrader ex-US portals

SAS Viewer

Adobe Acrobat Pro

MS Word

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 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.