Job Responsibility :

- Support regulatory dossier compilation, eCTD publishing, and submissions to US FDA, EMA, and global markets.
- Perform CMC document review for compliance with ICH guidelines, FDA/EMA requirements.
- Coordinate with cross-functional teams (Formulation, Analytical, QA, CROs) for submission readiness.
- Evaluate IIG compliance, elemental impurities (ICH Q3D), residual solvents (USP <467>), nitrosamines risk assessment, stability data, and specifications.
- Assist in deficiency response preparation (IR, DRL, CRL) and controlled correspondence drafting.
- Support regulatory strategy and ANDA submissions.
- Conduct regulatory impact assessment for change controls.
- Ensure submission quality check, completeness, and eCTD sequence validation prior to filing.
- Maintain submission trackers, technical documentation, and compliance records.

Qualification & Experience :

B. Pharma / M. Pharma

4–6 years in Regulatory Affairs (CMC, ANDA)

📌 Senior Executive – Regulatory Affairs (CMC) (Hyderabad)
🏢 Granules India
📍 Hyderabad