Juan Pablo Boada Rozo Email & Phone Number

Bogotá, Distrito Capital, Colombia

Technical director. Identify regulatory complexity and challenges and propouse creative solutions. Execute operational strategy and expectations for maintenance marketing licenses and essential documents. Preparation, reciept of local authority audits and implementation of improvement and correctives activities. Dossier updating in accordance with resolution 62542 of 2020, Evaluation of CMC documents. Impact assessments for changes in raw materials, manufacturing process and analytical methods. Update artworks for armonization with Andean and CAMCAR region. Tracking and archiving process for Veeva system.

Bogotá, Distrito Capital, Colombia

Review, analysis and application of changes in the regulations applicable to the pharmaceutical managers sector (PBS, VMR, PMR).Review, homologation and application of the MIPRES codes for the correct billing of medicines in the health system.Verification of changes in the sanitary records of the items sold, guaranteeing the correct information on the different platforms.Ensure the correct information in internal databases as transversal support in managerial decision making.Support in projects to expand the portfolio of articles of the family compensation fund.

Bogotá D.C., Colombia

Review, preparation and submission of new products to ensure their requirements before the Colombian regulator (INVIMA). Management and maintenance of the Company's Health Records. Reception and management of adverse drug events as well as its report to INVIMA. Review and adjustment of the art sketches of the old and new products of the portfolio. Support the marketing and sales team in the request for information necessary for the development of advertising material. Conduct product trainings in different regions of the country. Attend visits from the regulating entities of the sector such as INVIMA, Secretary of Health, ANLA and Ministry of the Environment.

Av Cra 19 # 95 - 55 Bogotá - Colombia

Review, preparation and submission of new products to ensure their requirements before the Colombian regulator (INVIMA). Management and maintenance of the Company's Health Records. Reception and management of adverse drug events as well as its report to INVIMA. Registration and maintenance of the company's brands. Review and adjustment of the art sketches of the old and new products of the portfolio. Support the marketing and sales team in requesting information necessary for participation in public and private tenders. Attend visits from the regulating entities of the sector such as INVIMA, Secretary of Health, ANLA and Ministry of the Environment.

Bogotá D.C.

Review, verification and request of requirements to the technical packages of national or imported products of chemical synthesis, submitted by the pharmaceutical industry in order to make changes (useful life, inserts, commercial presentations or labels) renewals and request for new sanitary registrations.

Personal attention to the internal and external client focused on the satisfaction of the requirements requested by the same, Pharmacological and pharmacotechnical evaluation of the projects, Evaluation of the competence products, Design and Development of formulations and reformulations for solids, semi-solids, liquids and steriles, Quote and requirement of the primary standards, Staging of manufacturing processes, Development of finished product analytical techniques by IR, UV and HPLC analysis, Elaboration of finished product specifications, raw material and packaging material, Mapping of processes in the research area according to requirements of ISO 9001-2008, Inventory management and requirements by the research laboratory.

Evaluate the quality of the finished product, according to the specifications, verification of the primary data (physicochemical and microbiological), produce the certificates of compliance, approval of the intermediate product and finished product, validation of analytical methodologies, verification of compliance of the scales, maintenance of the reagents and primary standards for the development of quality analysis.

Review, verification and adjustment of processes for continuous compliance with good manufacturing practices within manufacturing processes. Sampling of raw materials and finished products for the verification of quality status.

Master Of Business Administration (Mba), Business Administration And Management, General

Activities and Societies: Master en Administración y Dirección de Empresas.

Químico Farmacéutico, Dirección Y Admnistración De Empresas