Job Summary: Experienced R&D professional for supervision, coordination, and optimization of pharmaceutical product and process development, with a focus on regulatory compliance and team leadership. Key Highlights: 1. Leadership and R&D team development 2. Optimization of pharmaceutical formulations and processes 3. Experience with ANVISA, FDA, and EMA regulations **Requirements:** * Experience supervising/coordinating product and process development activities, including technical guidance of the team, task assignment, priority setting, and tracking of deliverables and results. * Experience in developing and optimizing formulations and process parameters for various pharmaceutical dosage forms, ensuring technical feasibility, reproducibility, quality, and compliance with manufacturing requirements. * Solid knowledge of national and international regulations applicable to drug development and registration, with practical experience in ANVISA, FDA, and EMA requirements. * Experience defining, managing, and monitoring performance indicators using metrics to track timelines, efficiency, quality, and project progress. * Involvement in R\&D team development, promoting technical training, strengthening execution capabilities, and aligning with company performance indicators and strategic objectives. * Experience preparing, reviewing, and consolidating technical documentation for regulatory submissions, ensuring technical consistency, information traceability, and compliance with applicable requirements. * Responsibility for ensuring adherence to Good Manufacturing Practices (GMP) in projects, as well as compliance with internal procedures, Quality Assurance policies, and current regulatory requirements. Experience supervising/coordinating product and process development activities, including technical guidance of the team, task assignment, priority setting, and tracking of deliverables and results. * Experience in developing and optimizing formulations and process parameters for various pharmaceutical dosage forms, ensuring technical feasibility, reproducibility, quality, and compliance with manufacturing requirements. * Solid knowledge of national and international regulations applicable to drug development and registration, with practical experience in ANVISA, FDA, and EMA requirements. * Experience defining, managing, and monitoring performance indicators using metrics to track timelines, efficiency, quality, and project progress. * Involvement in R\&D team development, promoting technical training, strengthening execution capabilities, and aligning with company performance indicators and strategic objectives. * Experience preparing, reviewing, and consolidating technical documentation for regulatory submissions, ensuring technical consistency, information traceability, and compliance with applicable requirements. * Responsibility for ensuring adherence to Good Manufacturing Practices (GMP) in projects, as well as compliance with internal procedures, Quality Assurance policies, and current regulatory requirements. **Desirable:** MBA and Intermediate English. **MORE DETAILS** ----------------- ### **Location** Anápolis ### **Shift** Administrative ### **Education** Bachelor's Degree in Pharmacy.
João Silva
Indeed · HR
João Silva
Indeed · HR
