Principal Regulatory Operations Publisher

Veristat

. Independently lead publishing projects to successful completion .

Posted 10/30/2026full-timeRemote • North Carolina • United States, Canada, IndiaLead💰 $100,000 - $120,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

Use this summary to align your resume positioning with the role.

Demonstrates expertise in regulatory publishing, including leading major dossier submissions and managing project teams. Proficient in using publishing software and medical terminology, with strong writing and communication skills.

Highest-signal resume keywords

Regulatory PublishingProject LeadershipGlobal SubmissionsAdobe AcrobatMedical Terminology

ATS Keywords

Tailor your resume

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills

Regulatory PublishingProject ManagementDossier SubmissionAdvanced FormattingMedical Terminology

Soft Skills

Attention to DetailVerbal CommunicationInterpersonal CommunicationMentoring

Tools & Technologies

Adobe AcrobatISIToolboxECTDmanagerDocuBridgeECTDXpressMicrosoft WordEndNote

Industry Keywords

Contract Research OrganizationPharmaceuticalBiotechnologyClinical SettingFDAEMA

About the role

Key responsibilities & impact

Independently lead publishing projects to successful completion
Internally support Medical Writing, Biostatistics, Programming, and Regulatory Affairs teams
Lead the finalization and publishing of regulatory documents for electronic submission
Represent the Regulatory Operations group in critical business activities
Mentor junior team members
Act as a point of escalation for technical questions and troubleshooting

Requirements

What you’ll need

Bachelor’s Degree, preferably in a scientific discipline, with at least 8 years of relevant experience in regulatory publishing in a contract research organization (CRO), pharmaceutical, biotechnology, or other clinical setting required
Proficiency in Adobe Acrobat, ISIToolbox, publishing software (e.g., eCTDmanager, DocuBridge, eCTDXpress, etc.) and advanced formatting using Microsoft Word styles and templates, including EndNote software required
Demonstrated ability to effectively lead a project team required
Demonstrated ability to independently manage major dossier submissions or amendments of varying complexity and scope required
Experience with global submissions (including FDA and EMA) and post-marketing submissions strongly preferred
Excellent writing skills (eg, English usage), a keen attention to detail, and strong verbal and interpersonal communication skills required; ability to serve as a consultative partner therein
Proficiency with medical and statistical terminology required
Ability to communicate and collaborate effectively in project teams required

Benefits

Comp & perks

Remote working
Flexible time off
Paid holidays
Medical insurance
Tuition reimbursement
Retirement plans
Applicable bonus