Vice President of Regulatory Strategy

2 weeks ago


Columbia, South Carolina, United States Mantell Associates Full time

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 lista 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 desarrollar 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, SOPs, desarrollo de negocios, etiquetado clínico, divulgación) según sea necesario.

Vicepresidente de Estrategia Regulatoria - Requisitos:

  • Se requiere educación en ciencias de la vida.
  • Se prefiere experiencia en el ámbito respiratorio.
  • 5 - 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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