Pharma Regulatory Affairs Head job opportunity at Roche.

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DateMore Than 30 Days Ago bot
Roche Pharma Regulatory Affairs Head
Experience: General
Pattern: full-time
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loacation Mexico City, Mexico
loacation Mexico City....Mexico

At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections,  where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters. The Position Resumen del Rol El Head of Regulatory Affairs es responsable de definir y ejecutar la estrategia regulatoria para el portafolio de productos Roche en México. Su objetivo es garantizar el acceso oportuno de nuestras terapias innovadoras al mercado mexicano, asegurando el cumplimiento normativo ante la COFEPRIS. Como líder de área, actúa como enlace estratégico entre nuestra sede global en Basilea y la operación local, gestionando el talento interno para alcanzar los objetivos de negocio. La Posición Responsabilidades Estratégicas y Técnicas Aprobación de Portafolio: Diseñar rutas críticas de registro en México para productos biotecnológicos, biológicos y moléculas pequeñas, priorizando el uso de Reliance.. Inteligencia Regulatoria: Monitorear y analizar cambios en la Ley General de Salud, NOMs y guías de COFEPRIS para mitigar riesgos operativos. Gestión de Ciclo de Vida: Supervisar el mantenimiento de registros (prórrogas, modificaciones, etc.) para evitar interrupciones en el suministro comercial. Compliance y Calidad: Colaborar con el Responsable Sanitario en el cumplimiento de Buenas Prácticas de Fabricación y Almacenamiento, así como en auditorías internas y externas. Representación Institucional: Liderar la participación de la compañía en grupos de trabajo regulatorios de asociaciones industriales (AMIIF, CANIFARMA, AmCham). Responsabilidades de Liderazgo y Gestión de Personas Gestión de Talento: Reclutar, retener y desarrollar a un equipo de gerentes y especialistas, fomentando una cultura de alto desempeño y actualización científica constante. Mentoría y Coaching: Establecer planes de desarrollo individual (IDP) y asegurar la transferencia de conocimiento técnico especializado dentro del departamento. Gestión del Desempeño: Definir KPIs claros para el equipo y realizar evaluaciones periódicas de resultados. Presupuesto y Recursos: Administrar el presupuesto anual del área regulatoria, incluyendo el pago de derechos ante la Secretaría de Hacienda y contratos con terceros. Interacción con Stakeholders  Sede Global (Basilea, Suiza): Reportar el estatus regulatorio local y alinear las expectativas de lanzamiento globales con los tiempos de la autoridad mexicana. Unidades de Negocio (Comercial): Proveer asesoría regulatoria para el desarrollo de estrategias de marketing y ventas para los productos de Roche, asegurando que los materiales promocionales cumplan con la ley. Autoridades Sanitarias: Actuar como el contacto de primer nivel ante la COFEPRIS para la resolución de trámites y asuntos relacionados con la empresa Quién eres Formación: Licenciatura en áreas de la salud (QFB, Farmacia, Medicina, Biología). Maestría o Especialidad en Asuntos Regulatorios es altamente deseable. Experiencia: Mínimo 10-12 años en RA en la industria farmacéutica, con al menos 5 años en posiciones de liderazgo de equipos. Idiomas: Inglés fluido para comunicación constante con nuestro corporativo en Suiza. Competencias Soft: Negociación de alto nivel, visión estratégica, resiliencia, pensamiento analítico y ética inquebrantable. Esta posición no ofrece beneficios de relocación     Who we are A healthier future drives us to innovate. Together, more than 100’000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact. Let’s build a healthier future, together. Roche is an Equal Opportunity Employer.

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