Urimara Argotti Email & Phone Number

Cambridge, Ma, Us

México

● Led 15 regional regulatory policy projects, meeting 94% on time and cost in 24 months.● Managed all regulatory policy activities for 4 Roche oncology products for the region, including oversight of requirements, legislations, and regulatory environment.● Ensured 100% organizational awareness, alignment, and support for all units in the region through prioritization of activities and issues by building regulatory roadmaps for each country.● Improved 70% of capacity building in LATAM by including Roche's regulatory priorities, planning and organizing educational workshops with relevant local and regional regulatory agencies. ● Increased by ±80% strong relationships with health authorities through effective communications, interactions and participation in regionally focused meetings, conferences, and committees.● Built and fostered relationships with 8 commercial organizations and actively and led 5 industry or scientific working groups of importance for Roche.● Delivered 98% on time and within budget on all assigned projects by leading strategic plan activities. ● Positioned Roche in local chambers, LATAM Regional Chambers: FIFARMA, EFPIA LATAM Network, BioPhorum, BIO Local Chambers: AFIDRO (Colombia), ALAFARPE (Peru), AMIIF (Mexico), ARAPF (Dominican Republic), CAEME (Argentina), CEFA (Uruguay), CIF (Chile), FEDEFARMA (Central America), INTERFARMA (Brazil), IFI (Ecuador). ● Designed the strategic plan for FIFARMA of the regulatory and pharmacovigilance group in 2021-2022, 2022-2023 and 2023-2024.● Boosted in 50% innovation topics’ progress by means of strategic business vision and connection with the actors involved.● Created, developed the strategy and implemented the activities at a global level leading the LATAM Global Topic Leader project for Digital Dynamic Labeling for health literacy for the last 6 months.

Bogotá D.C., Colombia

Achievements: • Led 2 regulatory strategy projects for Latin American markets obtaining registration approval for the extension of the Hemophilia portfolio (Kovaltry and Kogenate FS) in 12 months.• Developed and implemented regulatory strategies for Colombia, Ecuador, Peru, Venezuela, Central America and the Caribbean based on interpretation of FDA and EMA regulations, policies and procedures.• Developed effective regulatory strategy solutions with multinational teams for diverse and complex commercial issues.• Led the launching of innovative molecules for Oncology, Hematology, Ophthalmology, Cardiology and Radiology with 100% compliance with regulatory issues. • Ensured timely submission and approval of regulatory deliverables to support the biologics portfolio, such as CTA, MAA and annual reports (PSURS and DSURS).• Drove global regulatory convergence strategies in the Andean and Central American countries through the development and implementation for the first time of a regional policy roadmap and associated positions.• Analyzed and built a business case to measure FTEs based on responsibilities, regulatory operational burden and number of SKUs handled, which had a positive impact integrating the team to the business, as well as innovating. • Led and coordinated the reformulation of Mexsana's portfolio with another ingredient, replacing triclosan, in conjunction with the commercial, quality, legal, compliance, production and global areas.• Negotiated with INVIMA to submit the post-registration changes of Mexsana's formulation, maintaining business continuity and not affecting the availability of the product in the sellout. • Guaranteed the availability of the Mexsana product in Ecuador, Peru and Mexico by creating a regulatory strategic plan with INVIMA for the extension of the execution term by the whole industry from 12 to 18 months, which was 100% complied with.

Venezuela

Achievements: • Implemented the regulatory strategy for the oncology product-STIVARGA-in coordination with the multidisciplinary teams of the organization achieving its approval in the allotted time.• Effectively led the transfer of 30 licenses equivalent to 90 SKUs for the merger of Merck Sharp & Dohme products from the Bayer Consumer Health portfolio.• Managed regulatory and quality inspections received at Bayer Venezuela manufacturing plant as Technical Director by international authorities in the Americas (INVIMA, DIGEMID, ARCSA and ANMAT).• Led an average of 30 meetings in 24 months on a routine and ad hoc basis within the function and transversally internally and with health authorities as a speaker.Responsibilities: • Be the Pharmaceutical Sponsor and Regent of the Bayer, S.A. Laboratory. • Responsible for planning and overseeing the regulatory activities, including resource allocation and prioritization of all processes for assigned programs and sets priorities for proposals • Lead the development and implementation of an effective regulatory affair to ensure best possible relations with the various regulatory agencies.• Responsible for the management processes people and outcomes within the reporting team.• Establish and develop appropriate regulatory submissions for product approvals.• Act as liaison between functional areas and business units with the rest of the rapid assessment team in the country-region.• Participate with management in communications with local regulators and trade associations. • Maintain current knowledge and depth of country, regulatory programs sub-region and the world of authority, policies and other important regulatory information that may affect the company's products and customers.• Prepare status reports for submission for review at meetings and by management.• Provide support to regional managers of RA and help with various projects.• Budget Management Regulatory Affairs Department.

Venezuela

Renew the Registration of the Utility of Medical Devices and Warehouse J & J Medical complying with the provisions of the Local regulation, updating all the databases local and regional information from Venezuela on health registrations, renewals pending, control samples for local analysis, control of legal documents and master data table list. Keep renewed the 1000 currently marketed products company. Improved effective communication giving a strategic service to internal and external customers of our business. Monthly Compliance planning objectives.•Be the Pharmaceutical Sponsor and Regent of the Importer and Distributor of Medical Devices and Diagnostic Equipment Johnson & Johnson Medical, SCS Venezuela.•Responsible for planning and overseeing the regulatory activities, including resource allocation and prioritization of all processes for assigned programs and sets priorities for proposals based on departmental goals and objectives and establishes schedules and assigns staff work.•Monitoring regulatory activities with CO and the regional team to ensure deadlines for product registration and key projects are met.•Lead the development and implementation of an effective regulatory affair to ensure best possible relations with the various regulatory agencies.•Establish and develop appropriate regulatory submissions for product approvals.•Manage the regulatory aspects of new product registration for goods bearing the address of a minimum of management.•Dashboard and management performance indicators.•Ensure timely and accurate communication with customers, anticipating the needs of business units and the plan incorporates the RA display.

Venezuela

Registration of the Representation Office and Warehouse the year 2008 when Nycomed opened its doors in Venezuela. Being in charge of the repatriation of the main product of the company -which is PANTOP- registry of products with the Rafael Rangel National Institute of Hygiene, guaranteeing launches in order to ensure continuity and evolution of the business of the company in Venezuela. •Being the Sponsoring Pharmacist and Registered Managing Pharmacist of the Representation Office.•Being responsible for planning, managing and controlling the activities that are carried out in the Area of Regulatory Affairs, in aspects related to obtaining the registration certificates for new products, maintaining the products that have already been registered and marketed, as well as filing the sanitary documents of the company with the competent organizations so as to legally market the products in the country. Likewise, managing the area of Pharmacovigilance fulfilling the corporate procedures, the regulations that are in effect and the products under licenses. •Being responsible for Processing the Release Status of Nycomed products as related to Quality. •Enforcing and following up the Quality System by means of mandatory training programs in the Region following Corporate policies. •Managing the risk and impact of sales in case of not obtaining approval for the registration of a new product within the specified period of time, which will have an impact on its launch. •Managing the risk and impact on sales in case the revalidation of a product registration is not obtained when the product has already been registered and marketed within the specific period of time, which would have an impact on the sales of the product, thus leading to provisional or definite suspension of its marketing activities.

Miami, Fl. Us

•Obtaining registration for new products and carrying out the proceedings for the corresponding Renewals of the products of Boston Scientific in the regulated countries of the Region, namely: Bolivia, Costa Rica, Ecuador, Guatemala, Panama, Perú and Venezuela.•Countries under my Jurisdiction: The whole of Latin America, except for: Colombia, Mexico, Puerto Rico, Brazil, Argentina, Uruguay and Chile. •Management of Data Bases for obtaining on time Documents for completing the dossiers of New Registration Certificates and / or Product Renewals.Having been able to obtain control in a record period of time of two months and a half over the 186 Sanitary Registrations of Medical Devices, which had a positive impact on the business accounting from a 8% to a 45% of the sales. Co-Marketing development, thus increasing sales by a 47%. Marketing Support from the technical point of view. I also participated in developing disseminating campaigns that helped increase Sales by a 12%. I know the Key Opinion Leaders and I have worked in order to solve their problems. Responsible for Quality Assurance and Pharmacovigilance. •Managing and Reporting the time frames set forth for the Complaint Report procedures (complaints about the products), Recalls (product recalls from the market) and Hold -in other words, keeping the products in a quarantine due to quality control problems of the Head Offices to be reported to Dual Control of two areas: Regulatory Affairs and Quality Assurance.

Venezuela

Within the framework of the Pharmaceutical Industry, obtaining the approval of the Revision Board of Pharmaceutical Products regarding the evaluation of an antineoplastic drug that is indispensable for the Venezuelan market, thus guaranteeing the quality of life of patients who buy their medication from BADAN. •Developing and recording the Dossiers for New Registration Certificates of Category A, B, C Products and Biological Products. •Developing and recording the Dossiers for the Renewal of Product Certificates. •Following up the proceedings for the New Registration Certificates, Renewals, Post-Registration Changes filed with the Rafael Rangel National Institute of Hygiene (INHRR, for its acronym in Spanish). •Acting with all the powers and attributes of the Assistant Pharmacist. •Being responsible for the requests for Import Permits for psychotropic drugs filed with the People’s Ministry for Health. •Registering the products with SENCAMER. •Coordinating the Project for standardizing the artwork and layout of printed materials, internal brochures, patient information leaflets and product documentation for Latin America, directly reporting to the Headquarters. •Coordinating with the Manufacturing plant of Valencia the products that will be locally conditioned.

Licentiate Degree, Health Economy

Master'S Degree, Management Business Administration, Mba

Specialization, Advanced Program Intellectual Property

Licentiate Degree, Senior Marketing Management Program For Companies

Licentiate Degree, Senior Management Program Of Health Center Administration

Bachelor Of Pharmacy (B.Pharm.), Major In Cosmetic Technology