Pharmaceutical Technical Director

Description

Position Summary: We are seeking a Pharmaceutical Chemist to lead regulatory processes, manage technical and legal documentation, and ensure regulatory compliance within a pharmaceutical company. Key Highlights: 1. Lead sanitary registration processes and regulatory compliance. 2. Manage technical and legal regulatory documentation. 3. Ensure compliance with Good Storage and Distribution Practices. Our client, a leading Peruvian pharmaceutical company specializing in the importation and commercialization of medical devices and OTC products, is seeking the following profile: **REQUIREMENTS:** * Professional degree in Pharmaceutical Chemistry (Mandatory). * Valid professional license (Mandatory). * More than 2 years of experience as Technical Director or in similar positions (e.g., Regulatory Affairs or Quality Management) in pharmacies or pharmaceutical laboratories. (Desirable) * Experience managing sanitary registrations for medical devices and/or pharmaceutical products (OTC). (Desirable) * Solid knowledge of Good Storage Practices (GSP) and Good Distribution and Transportation Practices (GDP). * In-depth understanding of applicable Peruvian health regulations (Law No. 29459 and current regulations). * Knowledge of DIGEMID regulations for medical devices and pharmaceutical products. * Proficiency in quality management systems (ISO 9001, ISO 13485\). * Intermediate-level proficiency in MS Office: Word, Excel, PowerPoint. * Familiarity with pharmacovigilance and technovigilance software. (Desirable) **RESPONSIBILITIES:** * Lead processes related to obtaining, renewing, modifying, and canceling sanitary registrations with regulatory authorities. * Manage required technical and legal documentation, ensuring its compliance and validity. * Represent the company before health authorities during audits and inspections. * Supervise compliance with labeling, inserts, and promotional material regulations. * Ensure compliance with GSP and GDP across the entire supply chain. * Design, implement, and maintain the quality management system. * Supervise storage, inventory, and distribution processes, ensuring optimal conditions. * Manage quality deviations, non-conforming products, returns, and market withdrawals. * Participate in supplier selection and evaluation. * Conduct internal and external quality audits. * Lead, train, and supervise the technical and warehouse teams. * Participate in strategic planning and development of new product lines. * Assess regulatory requirements for new products and business opportunities. * Provide technical and regulatory support in the development of proprietary products. * Ensure compliance with all applicable legal regulations. **WORK LOCATION**: Miraflores **WORK MODALITY**: 100% on-site **WORK HOURS**: Monday to Friday, 8:00 a.m. to 6:00 p.m. **BENEFITS**: * Formal employment under the General Regime \- Statutory benefits Please send your updated CV to: cv(arroba)selekto\-rrhh.com with subject line: Technical Director Application Questions: * Availability to assume this position. * Valid professional license. * What is your expected salary? / Is it negotiable or gross? Work Location: On-site employment