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.

Swal Corporation Ltd. (UPL) | Lanxess India Pvt. Ltd. (Chemtura Chemicals) − 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.