$1,000,000 Per Year
$2,200,000 Per Year
Leads regulatory strategy for new drug applications and product lifecycle. Manages a team of regulatory affairs executives and specialists. Oversees preparation and submission of dossiers to CDSCO and global agencies. Develops regulatory roadmaps for new products and line extensions. Reviews and approves all regulatory documents before submission. Maintains relationships with regulatory consultants and government contacts. Leads responses to major regulatory queries, show cause notices, and GMP inspections. Manages regulatory intelligence and monitors global regulatory changes. Coordinates pre-submission meetings with drug regulatory authorities. Ensures product labeling, patient information leaflets comply with regulations. Supports BD&L teams with regulatory due diligence for partnerships. Manages regulatory compliance programs and internal audit processes. Stays current with ICH Q&A guidelines, CDSCO amendments, and global reforms.