Regulatory & Start‑Up Specialist — Spain

Precision Medicine Group

Madrid

Presencial

EUR 60.000 - 90.000

Jornada completa

Hace 3 días

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Descripción de la vacante

Precision for Medicine is seeking a Regulatory and Start Up Specialist based in Spain to drive site activation readiness and manage regulatory submissions with authorities and ethics committees. The role requires coordination with cross-functional teams to align timelines, budgets, and documentation.

The ideal candidate will have a life sciences degree, experience in regulatory submissions, and fluency in English and Portuguese.

Formación

Bachelor's degree in life sciences or related field (ideally scientific/healthcare).
RN or Pharmacy qualification would be beneficial.
Experience in contracts and budgeting; regulatory submissions experience.
Fluent in English and Portuguese.

Responsabilidades

Deliver site activation readiness on time and with quality.
Prepare Clinical Trial Application forms and submission dossiers for authorities and ethics committees.
Interact with competent authorities and ethics committees; respond to their queries and maintain updates.
Maintain project plans and regulatory trackers; coordinate with study teams and Start Up Lead.
Translate and coordinate translations of documents; ensure site activation and IMP release readiness.