Executive - IRA
Core
Evaluation of regulatory documents, compilation of dossiers, and submissions to CDSCO-HQ for regulatory approval of drug substances and products in India.
Role type
Senior Regulatory Affairs Executive
Builds
Regulatory dossiers and submissions for drug registration and marketing approval in India
Domain
Pharmaceuticals / Regulatory Affairs
Required skills
Regulatory strategy evaluation, CMC document review, dossier compilation, submission management, label artwork checking, prescribing information preparation
Preferred skills
Cross-functional coordination, Phase IV application management, post-approval change management
Technologies
CDSCO portal, regulatory submission systems
Responsibilities
Evaluate regulatory strategies for product registration in India, review CMC and other documents, coordinate corrections with cross-functional teams, prepare cover letters and regulatory documents, compile regulatory dossiers, submit applications for CT, BE, and domestic manufacturing/marketing permissions, manage import and marketing approvals, compile IPC testing dossiers, handle post-approval changes and Phase IV CT applications, manage additional site notifications and condition compliance
Seniority
Mid-level, hands-on IC