Senior Regulatory Publishing Leader, Remote

Veristat; North Carolina; Hybrid; 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 is seeking a Principal Regulatory Operations Publisher to independently lead publishing projects and support cross-functional teams in finalizing and publishing regulatory documents for electronic submission.

You will mentor junior staff and serve as a point of escalation for technical questions, contributing to FDA/EMA global submissions with strong writing and publishing-tool proficiency.

Qualifications

• Bachelor’s Degree in a scientific discipline with 8+ years in regulatory publishing.
• Experience leading major dossier submissions for FDA/EMA.
• Experience with global submissions and post-marketing submissions.
• Proficiency in formatting using Word styles and templates; EndNote.
• Strong writing, English proficiency, and communication skills.

Responsibilities

• Lead publishing projects independently for regulatory documents.
• Mentor junior team members and serve as escalation for tech questions.
• Collaborate with Medical Writing, Biostatistics, Programming, Regulatory Affairs.
• Support electronic submissions and finalization of documents.
• Represent Regulatory Operations in business activities.

Skills

Regulatory publishing

Project leadership

Editing & writing

Attention to detail

Verbal communication

Education

Bachelor's degree in science

Tools

Adobe Acrobat

ISIToolbox

eCTDmanager

DocuBridge

eCTDXpress

MS Word (styles)

Job description

Veristat is seeking a Principal Regulatory Operations Publisher to independently lead publishing projects and support cross-functional teams in finalizing and publishing regulatory documents for electronic submission.

You will mentor junior staff and serve as a point of escalation for technical questions, contributing to FDA/EMA global submissions with strong writing and publishing-tool proficiency.