Spain Regulatory & Start-Up Specialist (Contracts Budgets)

Precision for Medicine; Madrid; Presencial; EUR 65.000 - 95.000; Jornada completa

Descripción de la vacante

Precision for Medicine is seeking a Regulatory and Start Up Specialist based in Spain to join our growing team. This role focuses on regulatory submissions, site start-up activities, contract and budget negotiations, and ensuring compliance with ICH-GCP and local regulations.

The ideal candidate will have experience in CRO or pharma settings, fluency in English and Spanish, and a track record of coordinating with regulatory authorities, ethics committees, and site contracts to activate trials on

Formación

• Bachelor’s degree in life sciences or nursing or equivalent.
• Pharmacy qualification or pharmacist experience is beneficial.
• Proven experience in contracts and budgeting negotiations.

Responsabilidades

• Prepare regulatory submissions and startup dossiers per local requirements.
• Interact with authorities and ethics committees; manage responses.
• Maintain project plans, trackers, and regulatory intelligence tools.
• Coordinate site activation activities and budget negotiation requirements.
• Translate/coordinate translations for regulatory documents.
• Collaborate with cross-functional teams to ensure on-time activations.

Conocimientos

English fluency

Spanish fluency

Portuguese nice to have

Strong communication

Organizational skills

Educación

Bachelor's degree in life sciences

Pharmacy qualification (beneficial)

Descripción del empleo

Precision for Medicine is seeking a Regulatory and Start Up Specialist based in Spain to join our growing team. This role focuses on regulatory submissions, site start-up activities, contract and budget negotiations, and ensuring compliance with ICH-GCP and local regulations.

The ideal candidate will have experience in CRO or pharma settings, fluency in English and Spanish, and a track record of coordinating with regulatory authorities, ethics committees, and site contracts to activate trials on