TECHNICAL DOCUMENTATION LEAD

Description

Position Summary: Compile technical dossiers for product registration in Mexico and abroad, ensuring regulatory compliance and quality to obtain sanitary registrations. Key Highlights: 1. Commitment to health and well-being with over 80 years of history. 2. Opportunity to transform the future of healthcare. 3. Promotion of equal opportunities, inclusion, and diversity. **Date:** May 18, 2026 **Address:** Carr. a San Isidro Mazatepec 7, JALISCO, MX **Company:** Grupo PiSA Live your purpose and make a difference with Grupo PiSA. With over 80 years of history, Grupo PiSA is a 100% Mexican company committed to the health and well-being of millions of people both in Mexico and internationally. Our growth reflects the effort, passion, and dedication of a team focused on excellence. Join us and become part of a company where every day is an opportunity to live "A Life in Service of Life". Together, we can transform the future of healthcare and leave a positive impact on the world! **Employee Type** Trust-based employee**Position Objective** Compile technical dossiers for registration procedures in Mexico and abroad for new products, reformulations, and evaluations of alternate manufacturers, ensuring all constituent information complies with Quality-by-Design (QbD) principles and applicable national and international regulations, with the aim of obtaining sanitary registrations without applicable observations.**Responsibilities and Activities** * Perform activities associated with the Quality Management System under a code of compliance with Good Manufacturing Practices (GMPs). * Request, prepare, and review documentation comprising the technical dossier for finished products for registration procedures. * Verify that documents authorized by COFEPRIS correspond to registration applications Experience * Pharmaceutical industry (preparation and handling of documentation and technical dossiers/Dossiers): 2 years. * Regulatory affairs: 1 year. Knowledge * National and international pharmacopoeias (FEUM, USP, EP, BP, JP) * International guidelines (ICH, FDA, EMEA) * Official Mexican Standards (NOM-059, NOM-072, NOM-073, NOM-177) * Fundamentals of analytical method analysis and validation. Education Bachelor's degree in Chemical-Pharmaceutical or Chemical-Biological Sciences or \*Related fields**Complementary Profile** Passport letter is mandatory. At Grupo PiSA, we prohibit violence and discrimination, promoting equal opportunities, inclusion, and diversity. Our selection processes are FREE OF CHARGE; report any irregularity to lineaeticagrupopisa@letica.email