Senior Executive – Regulatory Affairs (CMC)

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)

Work arrangement
No