Job Summary

We are seeking a highly detail-oriented Regulatory Publishing Specialist with 3–4 years of hands-on experience in dossier preparation, compilation, submission, and publishing for global regulatory markets. The ideal candidate will have strong exposure to electronic submissions and extensive experience using Veeva RIM Publishing tools and regulatory validators. This role supports end-to-end regulatory submission activities ensuring compliance with global health authority standards.

Key Responsibilities

• Prepare, compile, and publish regulatory submission dossiers for global markets (US, EU, RoW).
• Perform publishing activities for eCTD, NeeS, and paper submissions in accordance with regional regulatory guidelines.
• Manage lifecycle activities including submission creation, sequence compilation, and amendments.
• Conduct quality checks and document reviews to ensure accuracy, completeness, and compliance.
• Perform technical validation of submission packages using industry-standard validators and resolve validation errors.
• Support submission readiness, publishing timelines, and coordination with Regulatory Affairs and cross-functional teams.
• Maintain submission metadata, reports, and archives within publishing systems.
• Ensure compliance with global health authority requirements (FDA, EMA, MHRA, etc.).
• Participate in process improvements and maintain SOP compliance.

Required Qualifications & Experience

• Bachelor’s degree in Pharmacy, Life Sciences, or a related discipline.
• 3–4 years of experience in regulatory publishing, dossier preparation, compilation, and submission.
• Strong experience with global regulatory submissions.
• Hands-on expertise with Veeva RIM Publishing tools.
• Experience working with regulatory validators (e.g., Lorenz DocuBridge Validator, Extedo eValidator, or similar).
• Sound understanding of eCTD structure, granularity, and regulatory submission standards.
• Experience in document QC/review and submission quality checks.
• Familiarity with submission lifecycle management and regulatory timelines.

Technical Skills

• Veeva RIM (Publishing module – mandatory)
• Regulatory submission validators
• eCTD / NeeS formats
• Dossier compilation and publishing tools
• MS Office Suite (Word, Excel, PowerPoint)

Soft Skills

• Strong attention to detail and organizational skills
• Ability to manage multiple submissions and tight timelines
• Good written and verbal communication skills
• Team-oriented with a proactive and quality-focused approach

Preferred Skills (Nice to Have)

• Experience with multiple health authorities and regions
• Understanding of regulatory intelligence and submission planning
• Exposure to inspection readiness or audit support activities

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