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