Regulatory Affairs Leader

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, biosimilares, innovadores de marca y productos de salud para el consumidor. Con sede en Toronto y oficinas regionales 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.

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, biosimilares, innovadores de marca y productos de salud para el consumidor. Con sede en Toronto y oficinas regionales 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 Summary

Contribute 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 such that we meet the business needs in a timely manner through applying smart regulatory strategies , active participation in meetings with the BU
• Complete any other duties as assigned by the Manager

Job Requirements

• Education
  • Degree in BSc , QFB , QFI or related career
• Knowledge, Skills and Abilities
  • Focus on our customers.
  • Teamwork and flexibility.
  • Strong attention to detail and problem-solving abilities.
  • Fluent Advance spoken and written English
• Experience
  • 5 years of experience in regulatory affairs area in pharmaceutical industry.
  • Experience in Generics, OTC Medicines, food supplements and specialty pharmaceuticals for Mexico and LATAM region.
  • Knowledge of regulatory requirements in the pharmaceutical industry such NOM-059, NOM-073, NOM-072, NOM-177, NOM-051-SCFI, NOM-241, RTCA

En Apotex, estamos comprometidos con fomentar un entorno laboral inclusivo y accesible, donde todas las personas se sientan valoradas, respetadas y respaldadas para desarrollarse plenamente. Como parte de nuestro proceso de reclutamiento, ofrecemos adecuaciones según las necesidades individuales de las personas con discapacidad. Antes de programar una entrevista, por favor infórmanos si requieres de algún tipo de apoyo.