✅Oversee the regulatory activities of a portfolio containing more than 70 active licenses, including maintenances, label extensions, risk and budget management of insecticides, fungicides, and herbicides products✅Guarantee a portfolio renewal based on new product licenses annually, having 24 new approvals over a three-year period, which enabled the company to grow 56%✅Implement regulatory strategies to reduce the timeline for new license approvals from 7 years after submission (market… Show more ✅Oversee the regulatory activities of a portfolio containing more than 70 active licenses, including maintenances, label extensions, risk and budget management of insecticides, fungicides, and herbicides products✅Guarantee a portfolio renewal based on new product licenses annually, having 24 new approvals over a three-year period, which enabled the company to grow 56%✅Implement regulatory strategies to reduce the timeline for new license approvals from 7 years after submission (market mean) to 4 years, achieving successful results in the last 3 years with 9 new approvals between 1-4 years✅Lead a team responsible for preparing the regulatory dossiers for new submissions to MAPA (Ministry of Agriculture), ANVISA (Health Agency), and IBAMA (Environmental Institute)✅Prepare the team for future responsibilities constructing Individual Development Plans and providing actionable feedback✅Member of internal committees for strategic and technical discussions, in cooperation with Project, R&D, Quality and Marketing areas✅Member of industry groups (Associations and Union), with direct participation in technical discussions to propose improvements in the regulatory system ✅Participate in technical reevaluations (toxicological and ecotoxicological) triggered by the Authorities to reevaluate active ingredients already in the market, based on the current scientific knowledge✅Maintain close relationships with the Regulatory Authorities in order to follow up on the status of ongoing processes Show less

✅Elaborated and submitted regulatory dossiers including processes of technical products by equivalence, processes of formulated products, processes of new active ingredient, and processes of post-registration (label extensions, the inclusion of manufacturers, change of compositions, and others)✅Controlled projects and regulatory timelines to attend all demands within the deadlines✅Replied technical data call-ins issued by the Regulatory Authorities during processes… Show more ✅Elaborated and submitted regulatory dossiers including processes of technical products by equivalence, processes of formulated products, processes of new active ingredient, and processes of post-registration (label extensions, the inclusion of manufacturers, change of compositions, and others)✅Controlled projects and regulatory timelines to attend all demands within the deadlines✅Replied technical data call-ins issued by the Regulatory Authorities during processes evaluations✅Updated and reviewed labels and marketing materials to be in accordance with the product licenses✅Monitored GLP studies with a focus on the acute toxicological package, in-vitro mutagenicity, quantitative structure-activity relationship models (QSAR)✅Participated in the corporate Global Human Health Group, representing Brazil in agrochemical toxicology discussions✅Supported trainees and other specialists providing appropriate training, coaching, and mentoring Show less

✅Elaborated dossiers for new registration, renewal, and post-registration processes for generic and similar drugs for submission to ANVISA✅Controlled regulatory deadlines and compliance with various petition requirements✅Prepared and reviewed packaging labeling and marketing materials✅Monitored publications in the Federal Official Gazette✅Maintained close relationships with related areas of the pharmaceutical industry (Production, Quality Control, Quality… Show more ✅Elaborated dossiers for new registration, renewal, and post-registration processes for generic and similar drugs for submission to ANVISA✅Controlled regulatory deadlines and compliance with various petition requirements✅Prepared and reviewed packaging labeling and marketing materials✅Monitored publications in the Federal Official Gazette✅Maintained close relationships with related areas of the pharmaceutical industry (Production, Quality Control, Quality Assurance)✅Participated in change control discussions providing regulatory inputs✅Participated in legislations groups discussions Show less