Gerente de Asuntos Regulatorios

Propósito

Gestionar las actividades regulatorias para garantizar el cumplimiento de normativas locales e internacionales, alineando los objetivos regionales con las políticas corporativas.

Estrategia y cumplimiento regulatorio: Da soporte en registros, lanzamientos y mantenimiento del ciclo de vida de productos, asegurando el cumplimiento normativo y la actualización de bases de datos regulatorias.

• Representación y relaciones institucionales: Actuar como enlace con entidades regulatorias y la Cámara Farmacéutica, promoviendo iniciativas de Advocacy para influir en el entorno regulador.
• Supervisión de proyectos regulatorios: Coordinar y hacer seguimiento a proyectos clave, optimizando procesos y asegurando la entrega oportuna de hitos.
• Gestión documental y aprobación de materiales: Revisar y aprobar artes finales, garantizar la integridad de la documentación de registros y soporte en auditorías regulatorias.
• Optimización de sistemas regulatorios: Actuar como referente en sistemas y procesos regulatorios, brindando soporte a usuarios y asegurando su correcta implementación.
• Gestión de calidad: Identificar, evaluar riesgos, desvíos, analizar causa raíz y desarrollar CAPAS.

Calificaciones

• Título Farmacéutico o carreras afines.
• Experiencia en el mercado farmacéutico y regulaciones aplicables.
• Inglés avanzado (escrito y verbal).

• Experiencia requerida:
  • 2-3 años en posiciones similares dentro de la industria de la salud.
  • 3-5 años en asuntos regulatorios.

Valoramos el sentido de urgencia, así como excelentes habilidades interpersonales y de comunicación. Buscamos profesionales con capacidad de adaptación a cambios internos y externos, así como a las tendencias y desarrollos en el entorno regulatorio que puedan impactar a GSK. Además, consideramos fundamentales las habilidades sólidas para la resolución de problemas y la toma de decisiones.

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.