Senior Regulatory Publishing Lead - Remote

Veristat; British Columbia; Remote; CAD 140,000 - 168,000; Full time

Benefits offered by this job

Remote working

Flexible time off

Paid holidays

Medical insurance

Tuition reimbursement

Retirement plans

Job summary

Veristat is seeking a Principal Regulatory Operations Publisher to independently lead publishing projects and support Medical Writing, Biostatistics, Programming, and Regulatory Affairs teams in finalizing and publishing regulatory documents for electronic submission.

The role includes mentoring junior members, representing Regulatory Operations in key activities, and serving as a technical escalation point. Strong leadership and regulatory publishing expertise are required.

Qualifications

• Bachelor's degree in a scientific discipline required.
• At least 8 years of regulatory publishing experience in CRO/pharma/biotech or clinical setting.
• Experience leading major dossier submissions or amendments.

Responsibilities

• Lead publishing projects to success and support cross-functional teams.
• Oversee finalization and publishing of regulatory documents for electronic submission.
• Mentor junior team members and act as escalation point for technical questions.
• Represent Regulatory Operations in critical business activities.
• Independently manage major dossier submissions or amendments.

Skills

Project leadership

Excellent writing

Verbal/interpersonal communication

Regulatory terminology

Collaboration in cross-functionalteams

Education

Bachelor's Degree in a scientific discipline

Tools

Adobe Acrobat

ISIToolbox

eCTDmanager

DocuBridge

eCTDXpress

EndNote

Microsoft Word (styles/Templates)

Job description

Veristat is seeking a Principal Regulatory Operations Publisher to independently lead publishing projects and support Medical Writing, Biostatistics, Programming, and Regulatory Affairs teams in finalizing and publishing regulatory documents for electronic submission.

The role includes mentoring junior members, representing Regulatory Operations in key activities, and serving as a technical escalation point. Strong leadership and regulatory publishing expertise are required.