Aarti Saxena

− Prepared and submitted chemistry, residue, and compliance dossiers under Health Canada (PMRA) requirements, ensuring all documentation met regulatory standards within required timelines. − Built and maintained a Regulatory Tracking System to monitor submission milestones across a 120+ product portfolio, improving adherence to timelines and reducing manual tracking errors. − Documented and applied CAPA protocols and root-cause gap analysis to address regulatory deficiencies, contributing to a 40% reduction in repeat deficiencies across multi-product dossiers. − Coordinated with vendors and internal teams to track submission progress and follow up on action items, supporting timely responses to Health Canada review cycles. − Maintained label and SDS compliance across the commercial product portfolio, identifying and resolving compliance gaps in coordination with distribution partners. − Provided regulatory support to QA and RA team members on dossier preparation, portfolio compliance, and documentation best practices, fostering a culture of regulatory accountability and continuous improvement.

− Supported Agile-based validation of IT systems used in Quality Management and regulatory compliance, ensuring documentation met ICH and FDA data integrity requirements. − Contributed to documentation control improvements aligned with GMP standards, including SOP compliance and electronic record-keeping practices.

− Prepared and submitted regulatory dossiers for 5 novel agrochemical product registrations from inception through authority approval across India and international export markets. − Compiled and reviewed chemistry summaries and technical data packages to support submission review and reduce back-and-forth with regulatory authorities. − Engaged with regulatory authorities during pre-submission meetings to clarify requirements and support efficient approval processes. − Coordinated with CROs and internal teams to gather and organize supporting data for dossier preparation and submission tracking.

− Provided regulatory support for generic off-patent registrations, export and import registrations, agrochemical dossier preparation, label compliance reviews, CRO coordination, GLP documentation, technical data packages, submission tracking, gap analysis, and product registration activities.

− Performed HPLC, GLC, and UV Spectrophotometer analysis; conducted residual analysis, formulation testing, raw material and in-process testing, and finished product batch analysis under GLP and GMP conditions. − Prepared Certificates of Analysis (COA), SOPs, and QC documentation; supported instrument calibration, qualification, and stability testing activities.