Experience

Actelion (now Janssen Pulmonary Hypertension)

• Switzerland
• Pharmaceutical Manufacturing
• 500 - 600 Employee

• Director de Asuntos Regulatorios y Calidad

  • Oct 2009 - Present

  Implementación, mantenimiento y mejora Àrea regulatoria Implementacion, mantenimiento y mejora Sistema de calidad Implementacion, mantenimiento y mejora de Compliance Implementacion, mantenimiento y mejora del sistema de auditorias Estrategia y Registro de medicamentos huerfanos Estrategia y Registro de medicamentos de alta especialidad Definición de la estrategia regulatoria para la comercializacion de los productos de la compañía Definición de la estrategia de calidad Definición e implementación de la mejor estrategia para el posicionamiento y lanzamiento de los productos de la compañía através de equipos multidisciplinarios



Actelion Pharmaceuticals México

• Drug Regulatory Affairs and Quality Director

  • Oct 2009 - Present

  Responsibilities / Activities: Definition and follow up to the regulatory strategies for the company's products. Coordination and follow up to regulatory applications with MoH; new products approval, variations, import licenses, promotional materials, etc. Coordination of translation of documents needed for the business operation. Assure compliance with current regulation. Knowledge and application of guidelines and rules for new products, renewal, labeling (NOM-072), Stability Norm (NOM-073), GMP´s (NOM; Act as Sanitary Responsible. Act as leader in the Quality System implementation, CAPA´s, third party contractors, etc. Definition and implementation of strategy for new products launch. Lobbying with decision makers. Act as point of contact in regional activities with HQ for drug regulatory activities, Quality system, Compliance, Pharmacovigilance, to implement activities locally. Acts as Compliance Champion Company: JANSSEN-CILAG; S.A. de C.V.



Janssen-Cilag México

• Drug Regulatory Affairs

  • Aug 2004 - Sep 2009

  Responsibilities / Activities: Mexico's registration renewal process leader. To coordinate regulatory affairs specialists in order to meet with renewal process compromises. Knowledge, apply and comply of new products registration guidelines, renewal guidelines, NOM-072 (labeling), NOM-073 (stability), NOM-059 (good manufacturing practices; Responsible of maintain updated and available for commercialization the products of central nervous system, primary care and OTC business units. Regulatory strategy support in order to define new or changes in marketing strategies for old or new products.Coordination and follow-up to authorizations from SSA to regulatory activities; sanitary registrations; changes to registration conditions; inspection visits; free sales certificates; good manufacturing practices certificates; import-export permits to controlled and non-controlled products; raw materials and products release authorization; coordinate translation and update of information required for product's maintenance; annual prevision report for controlled products; term notices for stock exhausting, etc. Regional projects for resources optimization and implementation of working standards; coordinate, provide and update documentation for new products registration and renewals in Latin-American countries. Actively participation in pharmaceutical industry working groups.Company: JANSSEN-CILAG; S.A. de C.V.Position: Technical services and New Products Development / Validation

• Technical services and New Products Development / Validation

  • Mar 1999 - Jul 2004

  Coordinate activities of validation area. Process’s Validation (finished product and cleaning validation), analytical validation (finished product and cleaning validation), equipment’s qualification, critical system’s qualifications, analytical transfers (local and international), technology transfer, maintenance of documentation related to all area activities, training and follow-up to new personnel, SOP´s elaboration. Actively participation in projects for continuous improvement. Improvement working teams leader as bioluminescence implementation and cycle time reduction for release product. Laboratory responsibilities: standardizations, impurities test, technical documentation, and stability tests.Elaboration, perform and follow-up to validation/qualification/transfer protocols.ISO 9000:2000 auditor and support to Process Excellence teams.



LA ITALIANA S.A. de C.V

• Puebla de Zaragoza y alrededores, México

• Quality Control Analyst

  • Jan 1999 - Feb 1999

  Control, analysis, statistics, report and supervision of raw materials. Control, analysis, statistics, report and supervision of raw materials.