Regulatory Submission Publisher

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 tools

3. 3 - 5+ years in regulatory publishing experience