— Regulatory Consulting Role Overview Key Focus Areas Provides expert strategic counsel to pharmaceutical Registration, renewal, and variation strategies clients on regulatory pathways for innovative/generic Accelerating market entry products, medical devices, and cosmetics. Ensuring compliance within Mexico

Company Launch Team Leadership Architected the regulatory framework to launch the Led and mentored teams in Regulatory Affairs, company's Mexico operations, securing the first Pharmacovigilance, and Quality Assurance, critical registration approvals (3 drug products, 1 establishing a robust Quality Management System.medical device). Authority Relations Pipeline Management Served as the registered Sanitary Responsible before Successfully recovered rights for a key drug product Cofepris, managing all high-level authority and managed a pipeline of 7 additional submissions. relationships and dossier submissions.

Company Launch Architected the regulatory framework to launch the company's Mexico operations, securing the first critical registration approvals (3 drug products, 1 medical device) Team Leadership Led and mentored teams in Regulatory Affairs, Pharmacovigilance, and Quality Assurance, establishing a robust Quality Management System Authority Relations Served as the registered Sanitary Responsible before Cofepris, managing all high-level authority relationships and dossier submissions. Pipeline Management Successfully recovered rights for a key drug product and managed a pipeline of 7 additional submissions

Directed regulatory strategy for new registrations, variations, Key Achievement and renewals across a complex portfolio of hospital-use 50% reduction in dossier compilation time through products. process optimization Oversaw regulatory operations for 10 Central American countries, managing a network of distributors and consultants. Achieved a 50% reduction in dossier compilation time through process optimization and strategic leadership. Key Achievement 50% reduction in dossier compilation time through process optimizatio

Held comprehensive responsibility for all regulatory activities for both generic (Ranbaxy) and innovator (Daiichi-Sankyo) product lines Quality System Implemented the NOM 059 quality system across the organization Renewal Program Developed the company's product renewal program from the ground up

Founded and operated a successful consultancy specializing in the translation of Pharmaceutical Technical Documents and regulatory consulting. Built a client portfolio including Roche and Chinoín, increasing business by 50% while reducing client costs by 25%

Founded and operated a successful consultancy specializing in the translation of Pharmaceutical Technical Documents and regulatory consulting. Built a client portfolio including Roche and Chinoín, increasing business by 50% while reducing client costs by 25%.