Regulatory Submissions Specialist - ICH/eCTD Focus

MMS Holdings Inc; Austin (TX); Remote; USD 70,000 - 110,000; Full time

Job summary

MMS Holdings Inc is an award-winning, data-focused clinical research organization (CRO) known for a Great Place to Work certification and a collaborative culture. We support pharmaceutical, biotech, and medical device industries with rigorous data and regulatory submission solutions worldwide.

We are seeking a Regulatory Operations/Publishing professional to manage regulatory document publishing, tracking, and submissions in alignment with ICH eCTD standards, working closely with

Qualifications

• Minimum 3 years in Regulatory Affairs or related field.
• College graduate in scientific/medical discipline, masters preferred.
• Proficiency with MS Office and Adobe Acrobat.
• Familiarity with ISO 9001 and ISO 27001 standards.
• Familiarity with 21 CFR Part 11, FDA, and GCP requirements.
• Experience with eCTD publishing and regulatory submissions.
• Strong communication and problem-solving skills.
• Understanding of CROs and regulatory data terminology.

Responsibilities

• Publish regulatory documents to eCTD format.
• Prepare and compile documents for regulatory submissions.
• Maintain submission project plans and track components.
• Perform quality control checks on documents and submissions.
• Coordinate with CROs, Authorized Agents, and vendors.
• Manage multiple regulatory submissions and timelines.
• Gains understanding of eCTD structure.

Skills

Regulatory knowledge

Publishing

Documentation management

Quality control

Problem-solving

Communication skills

Team collaboration

ISO 9001 knowledge

GxP awareness

Education

College graduate in scientific/medical discipline

Masters preferred

Tools

MS Office

Adobe Acrobat Professional

ISI ToolBox

eCTD publishing tool

SAS Viewer

eCTD Viewer

WebTrader/ex-US portals

Job description

MMS Holdings Inc is an award-winning, data-focused clinical research organization (CRO) known for a Great Place to Work certification and a collaborative culture. We support pharmaceutical, biotech, and medical device industries with rigorous data and regulatory submission solutions worldwide.

We are seeking a Regulatory Operations/Publishing professional to manage regulatory document publishing, tracking, and submissions in alignment with ICH eCTD standards, working closely with