Regulatory Submission Publisher

3 weeks ago

Madurai Tamil Nadu India, Tamil Nadu 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 tools

3. 3 - 5+ years in regulatory publishing experience

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