Spain Regulatory Start-Up Expert - Contracts & Budgets

Precision Medicine Group; Madrid; Presencial; EUR 60.000 - 90.000; Jornada completa

Descripción de la vacante

Precision for Medicine in Spain is seeking a Regulatory and Start Up Specialist to join our growing team. The role focuses on regulatory submissions, start-up activities, and budget/contract negotiations for Spain.

The ideal candidate will have strong experience with CA/EC submissions, site activation, and working within CRO or biotech environments, as well as fluency in English and Spanish.

Formación

• Bachelor's degree in life sciences or related field.
• RN or equivalent combination of education, training and experience.
• Demonstrated experience in contracts and budgeting negotiation for Spain.

Responsabilidades

• Prepare Clinical Trial Application Forms and submission dossiers for CA/EC and local bodies.
• Coordinate with CA/EC for submissions and responses.
• Maintain project plans, trackers and regulatory intelligence tools for assigned studies.
• Develop start-up plans, IMP release requirements and essential document review criteria.
• Partner with sites and ensure alignment for site activation and budget negotiations.
• Coordinate translations of site documents and maintain TMF readiness.
• Keep updated on local clinical trial laws and distribute knowledge within PFM.

Conocimientos

Communication skills

Organizational skills

English and Spanish fluency

Portuguese knowledge (a strong plus)

Educación

Bachelor's degree in life sciences

RN or equivalent

Pharmacy/ Pharmacist experience

Advanced degree in medical or life sciences / RAC

Descripción del empleo

Precision for Medicine in Spain is seeking a Regulatory and Start Up Specialist to join our growing team. The role focuses on regulatory submissions, start-up activities, and budget/contract negotiations for Spain.

The ideal candidate will have strong experience with CA/EC submissions, site activation, and working within CRO or biotech environments, as well as fluency in English and Spanish.