Site Name: Quito Edificio Torre 6 Office Posted Date: Dec 22 2024 En GSK, buscamos un(a) Coordinador(a) de Asuntos Regulatorios apasionado(a) y proactivo(a) para unirse a nuestro equipo. En este rol, serás clave para asegurar que nuestros productos farmacéuticos cumplan con las regulaciones locales y globales, apoyando el proceso de registro sanitario, renovaciones y modificaciones, además de colaborar estrechamente con diversas áreas de la empresa para mantener la calidad y la seguridad de nuestros productos. Responsabilidades: Desarrollo y mantención de procedimientos: Facilitar la implementación de nuevos procedimientos derivados de cambios regulatorios o políticas internas, así como realizar entrenamientos sobre procesos, políticas y actualizaciones. Gestión de registros sanitarios: Ejecutar actividades relacionadas con la solicitud de registros sanitarios, variaciones asociadas a calidad, seguridad y eficacia de los productos, y renovación de licencias conforme a la normativa local. Soporte a áreas internas: Colaborar con las áreas de Calidad y CS&L para mantener los productos conforme a la normativa local y los procedimientos internos de GSK. Cumplimiento regulatorio: Asegurar el cumplimiento de políticas y procedimientos internos para identificar y mitigar riesgos regulatorios, revisión de Gap Analysis, cierre de CAPAs, y otras acciones necesarias. Actualización de sistemas y plataformas: Mantener actualizadas las plataformas y sistemas regulatorios locales y corporativos. Participación en reuniones regulatorias: Asistir a reuniones locales relacionadas con las licencias de productos, brindando soporte en la obtención de aprobaciones regulatorias. Cualificaciones y Requisitos: Título universitario en Químico Farmacéutico o Bioquimíco Farmacéutico. Al menos 2 años de experiencia en Asuntos Regulatorios en la industria farmacéutica. Conocimiento en normativas regulatorias locales y procedimientos corporativos. Nivel intermedio-avanzado de inglés Why GSK? Uniting science, technology and talent to get ahead of disease together. GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology). Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together. Important notice to Employment businesses/ Agencies GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site. Our inclusive workplace makes our employees feel engaged by the contribution they make, by affording them equal treatment regardless of actual or perceived characteristics. As so, when you apply for a job at GSK, it is not necessary to include on your resume information such as: race, color, ethnicity, age, gender, sexual orientation, marital status, religion, origin, photographs or any other personal characteristics. Find out what life at GSK is really like www.gsk.com.