Senior Officer - Regulatory Affairs - High-Q Pharmaceuticals
Handled DRAP regulatory submissions for new product registrations, including dossier preparation and compliance checks. Managed international product and company registrations across multiple regions while ensuring alignment with applicable regulatory expectations. Took ownership of post-registration variations, renewals, CPI/hardship pricing applications, and regulatory tender support. • Prepare and submit DRAP registration dossiers for new products • Manage international registrations and regulatory queries across Asia, Africa, and the Middle East • Manage post-registration variations, renewals, and CPI/hardship pricing applications • Review artworks for DRAP label/packaging compliance and address tender/DTL queries
2023 - 2025