Acerca de Apotex Inc.
Apotex es una empresa global de salud con sede en Canadá. Mejoramos el acceso diario a medicamentos y productos de salud asequibles e innovadores para millones de personas en todo el mundo, con un amplio portafolio de productos farmacéuticos genéricos, biosimilar es, innovadores de marca y productos de salud para el consumidor. Con sede en Toronto y oficinas region ales a nivel mundial, incluyendo Estados Unidos, México e India, somos la empresa farmacéutica más grande con sede en Canadá y un socio de salud preferido en las Américas para licencias farmacéuticas y adquisiciones de productos.
Acercade Apotex Inc.
Apotex es una empresa global de salud con sede en Canadá. Mejoramos el acceso diario a medicamentos y productos de salud asequibles e innovadores para millones de personas en todo el mundo, con un amplio portafolio de productos farmacéuticos genéricos, biosimilar es, innovadores de marca y productos de salud para el consumidor. Con sede en Toronto y oficinas region ales a nivel mundial, incluyendo Estados Unidos, México e India, somos la empresa farmacéutica más grande con sede en Canadá y un socio de salud preferido en las Américas para licencias farmacéuticas y adquisiciones de productos.
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Job SummaryContribute to the increase and maintenance of the product portfolio in a timely manner for their commercialization, implementing actions for the submission, modification and/or renewal of the sanitary registration in LATAM markets; ensuring that comply with current national and international regulations. Carrying out the following deliverables: complete and correct files, monthly activity plan, monthly KPI review, update of the RIMS (Regulatory Information Management System) database in each authorization and application, update of the Sanitary Records database permanently.
Job Responsibilities- Collect, review and send information for the preparation of "Dossiers for submissions, inclusions, renewals and/or modifications in LATAM according to the Business Unit in accordance with current Health Legislation, Laws, Regulations, Decrees, Standards and Guides of each Country. applicable to the authorization of the Sanitary Registry,"
- Coordinate the request and delivery of samples for submissions, inclusions in the health sector, renewals and modifications for LATAM.
- Review and approve Artworks, in accordance with International Guidelines and Standards, NOM-072 and Labelling regulation.
- Prepare/update/correct labels of the company's products in accordance with LATAM Regulation obtaining the corresponding authorization.
- Prepare applications for certificates of free sale, good manufacturing practices, import/export of samples, among others, for submission to COFEPRIS and different countries in accordance with procedures to be included in the dossiers according to the Business Unit
- Keep the internal and corporate databases updated in accordance with the procedure so that all those involved in the processes are duly informed about the status of each of the products and submissions so that the processes are coordinated as authorized.
- Distribute controlled copies of current sanitary registrations in accordance with the procedure so that interested parties are informed and the flow in the marketing process continues in a timely manner.
- Analyze/Evaluate changes in the regulatory environment and their impact in the operation of the company, subsidiaries and business unit in order to consider any regulatory area that could affect the commercialization of products.
- Support to the corresponding Business unit , being the point of contact, providing regulatory feedback regarding status , coming up with the right RA strategy for the business unit requirements…
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