Regulatory Submission Publisher

3 days ago


tamil nadu, India Aurolab Full time

Purpose: Regulatory Submission Publisher will be responsible for assisting in the compilation, formatting, publishing, and validation of regulatory submissions in eCTD and non-eCTD formats. The role will provide exposure to global regulatory submission requirements for agencies such as US FDA, EMA, Health Canada, MHRA, and others.Responsibilities:• Assist in publishing regulatory submissions (NDA, ANDA, MAA, variations, IND, DMF, etc.) in eCTD and NeeS formats.• Support preparation of submission-ready documents by ensuring compliance with global health authority specifications and internal publishing standards.• Perform document formatting, bookmarking, and hyperlinking in accordance with agency requirements.• Execute validation checks using publishing tools to ensure submissions are compliant (no validation errors).• Assist in timely delivery of submissions to global health authorities through electronic gateways (e.g., ESG for FDA, CESP for EMA, etc.).• Maintain archival and version control of submission packages in regulatory systems.• Collaborate with regulatory operations leads, submission managers, and medical writers to ensure smooth publishing workflows.• Support troubleshooting and resolution of technical issues in submission files.• Stay updated with changes in eCTD specifications, guidance, and publishing tools.Qualification & skills:1. B Pharm degree and/or equivalent experience in Chemistry, or related discipline.2. Familiarity with publishing tools3. 3 - 5+ years in regulatory publishing experience



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