Vice President of Regulatory Strategy
2 weeks ago
Mantell Associates se asocia con una empresa biofarmacéutica que está impulsando un cambio innovador en el ámbito respiratorio. Con una reciente aprobación de la FDA y un sólido pipeline, esta compañía biofarmacéutica está preparada para generar un impacto significativo en el sector.
Vicepresidente de Estrategia Regulatoria - Responsabilidades:
- Actuar como líder de pensamiento en asuntos regulatorios, definiendo la estrategia y el plan regulatorio para maximizar el éxito en la regulación.
- Proporcionar aportes estratégicos y operativos al equipo del programa para alcanzar los objetivos del programa, asegurando el cumplimiento de los requisitos regulatorios aplicables.
- Desarrollar una hoja de ruta regulatoria para informar y guiar la estrategia de compromiso con las agencias; colaborar con partes interesadas clave para crear e implementar un plan integral de compromiso regulatorio.
- Dirigir esfuerzos interfuncionales para garantizar la presentación oportuna de documentos regulatorios clave.
- Asegurar que los miembros del equipo del programa y las partes interesadas interfuncionales estén informados sobre eventos internos y externos que puedan afectar el éxito regulatorio.
- Brindar apoyo regulatorio para actividades interfuncionales (por ejemplo, procedimientos operativos estándar, desarrollo empresarial, etiquetado clínico, divulgación) según sea necesario.
Vicepresidente de Estrategia Regulatoria - Requisitos:
- Se requiere formación en ciencias de la vida.
- Se prefiere experiencia en el ámbito respiratorio.
- 5 a 7+ años de experiencia en la industria biofarmacéutica con un profundo entendimiento de los requisitos regulatorios.
- Experiencia liderando interacciones con la FDA.
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