Pharmaceutical Chemist and Innovation & Portfolio Development Analyst

I manage and evaluate new pharmaceutical product opportunities for portfolio incorporation, from molecule identification through preliminary feasibility assessment, regulatory strategy, and launch potential. I analyze dosage forms, presentations, installed manufacturing capacity, outsourced processes, market conditions, competitors, therapeutic indications, and tender history.

I coordinate with Purchasing, Costs, Production, Quality Control, Quality Assurance, Technical Management, Regulatory Affairs, international suppliers, and manufacturers. I review GMP certificates, certificates of analysis, technical documentation, product artwork, prospectuses, and registration documentation; I also prepare evaluation matrices, timelines, reports, indicators, and internal procedures for new product projects.

Prepared, submitted, and monitored dossiers for pharmaceutical product registrations, renewals, and modifications before DINAVISA/MSPBS. Managed regulatory product lifecycles, sanitary registration expirations, regulatory databases, and internal tracking reports.

Reviewed and updated prospectuses, labeling, technical data sheets, promotional materials, CTD dossiers, GMP certificates, certificates of analysis, free sale certificates, and manufacturer documentation. Supported regulatory compliance for pharmaceuticals, medical devices, and in vitro diagnostics, including supplier documentation, audits, health inspections, technical authority responses, and tender submissions.

Coordinated with Quality, Production, Logistics, Purchasing, Commercial teams, international manufacturers, and suppliers to ensure documentary traceability and compliance. Supported implementation of ISO 13485-based quality system criteria for medical devices.

Supervised manufacturing processes for GMP compliance and supported risk analysis, deviation monitoring, internal audits, batch record review, product release, and management of standard operating procedures. Performed statistical quality controls, charting, Cp/Cpk analysis, annual product reports, and trend analysis using Excel.

Supported pharmacovigilance activities, including suspected adverse drug reaction evaluation and follow-up, PSUR review, PGR/RMP maintenance, and post-marketing safety monitoring. Evaluated clinical, safety, efficacy, and technical documentation for locally introducing products supported by international regulatory approvals.

Contributed to regulatory pre-import evaluations, supplier and manufacturer coordination, and continuous improvement through corrective and preventive actions related to safety incidents.

Managed full-time pharmacy operations and prepared monthly management reports. Oversaw labor-related activities, SIP system handling, SAP system use, and operational compliance with pharmacy and public health regulations.

Ensured medicines and marketed products complied with DINAVISA requirements, reviewed product leaflets and labels, managed regulated medicines including psychotropics and narcotics, and handled medicine registration and renewal processes before DINAVISA.

Performed raw material analysis using high-performance liquid chromatography, infrared spectrophotometry, balances, reagents, and quality control equipment. Supported identification and characterization of chemical compounds through infrared analysis.

Reviewed and handled production and quality documentation in a pharmaceutical manufacturing environment.