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.

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).

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.

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.
• 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.
• 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.

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.
• 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.
• 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.

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.
• 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.
• 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.

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.
• 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.

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