Global Regulatory Submissions Specialist

MMS; Canton Charter Township (MI); In loco; USD 90.000 - 130.000; Tempo pieno

Descrizione del lavoro

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.

Competenze

• 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.

Conoscenze

Regulatory knowledge (ICH/FDA)

Regulatory submissions

Document publishing

Submission planning

Quality control

eCTD structure

Coordination with CROs/agents

Project tracking & risk management

Formazione

College degree in scientific/medical/clinical field

Master's degree preferred

Strumenti

MS Office

Adobe Acrobat Pro

ISI ToolBox

eCTD publishing tool

SAS Viewer

eCTD Viewer

WebTrader/ex-US portals

Descrizione del lavoro

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.