Senior Regulatory Publishing Lead — Remote

Veristat, LLC; North Carolina; Remote; USD 100,000 - 120,000; Full time

Benefits offered by this job

Remote working

Flexible time off

Paid holidays

Medical insurance

Tuition reimbursement

Retirement plans

Job summary

Veristat, LLC is seeking a Principal Regulatory Operations Publisher to lead publishing projects and finalize electronic submissions across global programs. This role also mentors junior staff and serves as a technical escalation point for publishing questions.

The position collaborates with Medical Writing, Biostatistics, Programming and Regulatory Affairs to ensure accurate, timely dossiers for FDA/EMA submissions, requiring extensive regulatory publishing experience and strong writing and

Qualifications

• Lead regulatory publishing projects end-to-end in CRO/pharma settings.
• Mentor junior team members and act as escalation for technical questions.
• Collaborate with Medical Writing, Biostatistics, Programming, Regulatory Affairs teams.

Responsibilities

• Lead finalization and publishing of regulatory documents for electronic submissions.
• Represent Regulatory Operations in critical business activities.
• Support cross-functional teams to ensure on-time submissions.

Skills

Regulatory publishing leadership

Project leadership

Strong writing

Attention to detail

Communication skills

Mentoring

Education

Bachelor's degree in a scientific discipline

Tools

Adobe Acrobat

ISIToolbox

eCTDmanager

DocuBridge

eCTDXpress

EndNote

Job description

Veristat, LLC is seeking a Principal Regulatory Operations Publisher to lead publishing projects and finalize electronic submissions across global programs. This role also mentors junior staff and serves as a technical escalation point for publishing questions.

The position collaborates with Medical Writing, Biostatistics, Programming and Regulatory Affairs to ensure accurate, timely dossiers for FDA/EMA submissions, requiring extensive regulatory publishing experience and strong writing and