Regulatory Submission Publisher

Purpose:

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