Role & responsibilities

Elite Biopharma Private Limited is looking for an experienced and detail-oriented Regulatory Affairs Manager with strong expertise in eCTD dossier preparation, regulatory submissions, Module 2 and Module 5, and GCC regulatory requirements.

The candidate will be responsible for managing regulatory affairs activities from dossier preparation through submission, deficiency responses, regulatory correspondence, and approval, while coordinating with clients, internal teams, consultants, and regulatory authorities.

The ideal candidate should have hands-on experience in CTD/eCTD compilation, Module 2 summaries, Module 5 clinical documentation, regulatory strategy, and GCC submissions, with a strong understanding of pharmaceutical regulatory requirements.

Preferred candidate profile eCTD / CTD Dossier Management

- Manage end-to-end preparation, compilation, publishing, and lifecycle management of CTD/eCTD dossiers.
- Review and coordinate preparation of Module 2,



Module 3, Module 4, and Module 5 documents as applicable.
- Have robust working knowledge of:

- Module 2 CTD Summaries
- Module 2.5 – Clinical Overview
- Module 2.7 – Clinical Summary
- Module 5 – Clinical Study Reports and Clinical Documentation
- Review clinical and regulatory documents for completeness, consistency, and regulatory compliance.
- Coordinate with CMC, Clinical, Nonclinical, Medical Writing, Pharmacovigilance, and other teams for dossier preparation.
- Ensure correct document placement, hyperlinks, bookmarks, metadata, naming conventions, and eCTD technical requirements.
- Manage eCTD lifecycle sequences, including initial submissions, variations, responses, renewals, and amendments.
- Perform quality checks of dossiers prior to submission.

📌 Regulatory Affairs Manager (Bengaluru)
🏢 Elite Biopharma Pharma
📍 Bengaluru