Mario Gutiérrez

REGULATORY AFFAIRS & QUALITY ASSURANCE EXPERT SENIOR CONSULTANT (on remote) Reporting to: Global Regulatory Affairs and Quality Director. Responsible for: · Develop and execute the best strategy to obtain license authorizations in various LATAM & APAC countries and Australia and supports the Global Quality Management System of the company. · Establish and execute the regulatory and Quality requirements to start operations in Mexico, as well as the obtaining of new registrations through a new subsidiary.     Main achievements: ·  Obtaining several medical devices products registration in Mexico, Argentina, Colombia, Costa Rica, Peru, Bolivia & Australia. ·        Supports the organization with regulatory strategies to get the registrations licenses on time.

Responsible for: Developing and implementing regulatory strategies and/or processes to ensure the obtaining of authorizations in time for the commercialization of new products, modifications and renewals. Provide regulatory support to the different areas of the organization according to business priorities. Monitor the regulatory environment evaluating the possible impact of changes or new regulations. Ensure adherence and monitoring of regulatory compliance of marketed products, promotional materials, advertising and communications. Interact and negotiate with the regulatory agency to ensure priority approvals and resolution of regulatory problems. Head of the Techno vigilance Unit before the CNFV and representative before AMID. Implement and update the Quality Management System, conduct internal trainings and customer service. Main achievements: • Obtaining priority license in less than 2 months, representing the sale of 10M EUR through active management before the regulatory authority. • 300% increase in sales by obtaining 6 registrations in 1 month for emergency COVID-19 when managing essential and priority use before the regulatory agency. • Reduction in 30% of submission times through improvements in the planning of requirements for the assembly of the dossier and effective communication with the regulatory area of the region. • Obtaining 100% of Carestream licenses at LATAM level through management and coordination with the representatives of each country in 2 months. • Qualification "A" in Global L2 audit carried out by the corporate, when implementing a pre-internal audit detecting deficiencies and deviations to processes, allowing correcting them in time and adapting them to the Quality Management System.

Responsible for: Establishing the best strategy to obtain authorizations for health licenses, modifications and renewals. Obtain import and release permits for the sale of the product. Head of the Pharmacovigilance unit before the CNFV. Maintain current legal and technical documentation for bidding purposes. Ensure adherence and regulatory compliance of the company operation and representative before CANIFARMA. Main achievements: • Obtaining Certificates of Good Manufacturing Practices of 2 manufacturing sites in Italy issued by COFEPRIS in 2 months allowing the participation of the company in public tenders generating sales for the Health Sector. • Preparation and authorization of a self-sampling procedure for biological products in 2 months, reducing product release times by COFEPRIS, placing the product for sale in less time and with a longer expiration date. • Assignment of sanitary registration rights in 2 months under the requirement of elimination of the plant, allowing the commercial operation of the company in less time.

Responsible for: Ensuring that all products comply with current local health regulations and quality standards. Develop and implement strategies for execution, licensing and maintenance of current licenses. Regulatory support to the organization. Interact and negotiate with the regulatory agency to ensure priority approvals and resolution of regulatory problems. Head of the techno vigilance unit and sanitary responsible. Representative before trade associations such as AMID, CANACINTRA, ASEMED. Main achievements: • Resolution of problem of 56 health licenses before COFEPRIS in 2 months, due to incorrect resolution by the authority. An internal work plan of priorities by blocks was managed and prepared together with the authority for its correction, reducing the impact on the company in its operation. • Review and update of descriptive information of 455,000 codes in the database in 2 months, allowing to ensure the importation, reducing penalties and losses to the company. • Application of "Lean Management" inn 1 month in conjunction with the commercial area making the process of launching new products more efficient, generating sales and profits in less time.

• Head of the Pharmacovigilance Unit and for preparation of Product Safety Update Reports (PSUR) and safety reports (ISM) of medications and medical devices for extension of health records. • Head of the company’s customer service center. • Responsible for generating, analyzing, evaluating and providing all scientific and regulatory medical support for the company's products (medications, medical devices, food supplements and cosmetics) for regulatory, marketing, commercial and advertising affairs, complying with the ethical and normative framework in force, thus achieving the continuous operation of the company. • Preparation of scientific medical justifications in order to change sections on ethical medications to OTC and for the authorization of new claims in television products and guidelines.

• Coordinator, implementer and monitor of phase IV research protocols, and those initiated by the researcher or medical department, complying with local and international regulations on research, ICH, GCP and corporate policies. • Responsible for supervising the planning, initiation, conduction and adherence to multicenter phase II and III research protocols, managing up to 12 protocols in order to obtain clinical data, complying with local, international and corporate regulations in research matters, ICH, GCP and pharmacovigilance standards. • Attained the implementation of a research site, in minimum time, for the study of a molecule of high priority for the company achieving the first place in enrollment worldwide.

• Responsible for preparing and obtaining the modifications to the conditions for medication registration and support for registration of new molecules, obtaining the registration of Fosamax Plus before COFEPRIS in three months. • Responsible for providing all information for the inclusion of MSD products in the Basic Inter-Institutional Chart and Basic Institutional Charts (SSA, IMSS, ISSSTE, SEDENA, PEMEX, SM and other agencies). • Design and implementation of a PNO for the development of label projects in order to standardize captions in accordance with NOM 072 on labeling of medications and to eliminate activities that do not generate value to the department (artwork review). • Medical support for the call center and website, answering questions and resolving patients doubts about drug products. • Review of IPP's and advertising material.

• Responsible for providing advice and support in health regulation matters for all classes of medical devices before COFEPRIS and for the preparation of dossiers for obtaining records with COFEPRIS. (Serving customers such as Abbott, Gambro, J&J, IL Diagnostics, Edwards, Phillips, Siemens, Biomet, GE, among others). • Implementation of databases and procedures to improve the service.

• Coordinator for the obtaining of health records and modifications to their medications and medical devices from three business units, along with two regulatory specialists under my charge to fulfill the objectives of the company. • Regulatory physician advising the MKT department on the development of new products. • Inclusion of new codes to the Basic Medications Chart.

• Preparation of dossiers and managing of the registration of medications and medical devices of various business units before the sanitary authority. • Winner of the Best Team Award at Intercontinental level for being the first country to obtain sanitary records of the Anesthesia line. • Head and regulatory contact of exports to coordinate and provide technical, scientific and legal information of products manufactured in Mexico to Baxter subsidiaries in the rest of the world (Intercontinental Region). • Attainment of the implementation of multilingual labels for Fenwal products to be exported to the European community, adhering to the European standard EN 980 on labeling, reducing production costs and implementing the same scheme for the LATAM region. • Preparation of the information to prescribe the medications for registration purposes. • Pharmacovigilance of blood products and supervision of advertising material.

• Patient care in outpatient clinic and hospitalization of the 4 basic specialities.