Global Regulatory Submissions Specialist

MMS Holdings Inc; Phoenix (AZ); Remote; USD 85,000 - 110,000; Full time

Job summary

MMS Holdings Inc. in Phoenix seeks a Regulatory Affairs professional to manage document submissions and regulatory operations for clinical trial data. You will maintain eCTD submissions, ensure client style guides compliance, and coordinate with CROs and agents.

The role requires a scientific background, 3+ years experience, and proficiency with MS Office and publishing tools. This position offers opportunities to work on submission-ready documents and regulatory challenges in a collaborative

Qualifications

• College graduate in scientific, medical, clinical discipline or related field, or years of relevant experience.
• Minimum of 3 years’ experience in Regulatory Affairs, Regulatory Operations, Publishing or similar field.
• Gains understanding of MS Office and Adobe Acrobat Pro, ISI ToolBox, eCTD publishing tools.
• Expert knowledge of scientific principles and concepts.
• Proficiency with MS Word Formatting, Adobe and other MS Office applications.
• Hands-on experience with clinical trials and pharmaceutical development preferred.
• Good communication and problem-solving skills.
• Familiarity with ISO 9001 and ISO 27001 standards preferred.
• Familiarity with 21 CFR Part 11, FDA, and GCP requirements.

Skills

Regulatory Affairs

Regulatory Operations

Document Management

ICH eCTD

Submission Publishing

Quality Control

CRO Coordination

Project Tracking

Communication Skills

Problem Solving

Education

Bachelor's degree in life sciences

Masters preferred

Tools

MS Office

Adobe Acrobat Pro

ISI ToolBox

eCTD publishing tool

SAS Viewer

eCTD Viewer

WebTrader/ex-US portals

Job description

MMS Holdings Inc. in Phoenix seeks a Regulatory Affairs professional to manage document submissions and regulatory operations for clinical trial data. You will maintain eCTD submissions, ensure client style guides compliance, and coordinate with CROs and agents.

The role requires a scientific background, 3+ years experience, and proficiency with MS Office and publishing tools. This position offers opportunities to work on submission-ready documents and regulatory challenges in a collaborative