Spain Regulatory & Start-Up Specialist

Pfm; España; Presencial; EUR 45.000 - 65.000; Jornada completa

Descripción de la vacante

Precision Medicine Group in Spain is seeking a Regulatory and Start Up Specialist to lead regulatory submissions, site activation, and budget negotiations. The role requires coordinating with regulators, ethics committees, and site contracts, ensuring timely activations and compliance across Spain.

The ideal candidate holds a life sciences degree (RN or Pharmacist preferred) and has contracts/budgeting negotiation experience, fluent in English and Spanish, with strong communication and

Formación

• Bachelor's degree in life sciences or related field.
• RN or Pharmacist qualification would be highly beneficial.
• Demonstrated experience in contracts and budgeting negotiation.
• Fluency in English and Spanish.

Responsabilidades

• Prepare regulatory submissions (CTA forms and dossiers) for local authorities and ethics committees within required timelines.
• Interact with competent authorities and ethics committees, handling responses.
• Provide updates to study teams on regulatory submissions and timelines.
• Maintain regulatory trackers and start-up plans for assigned country/sites.
• Coordinate with site contracts management on budgets and essential documents.
• Translate and coordinate translations for project documents.
• Ensure site activation readiness and regulatory compliance across Spain.

Conocimientos

Fluent English and Spanish

Strong communication skills

Organizational skills

Regulatory/start-up experience

Educación

Bachelor's degree in life sciences

RN or Pharmacist qualification

Herramientas

Spreadsheets

Word processing

Email

Descripción del empleo

Precision Medicine Group in Spain is seeking a Regulatory and Start Up Specialist to lead regulatory submissions, site activation, and budget negotiations. The role requires coordinating with regulators, ethics committees, and site contracts, ensuring timely activations and compliance across Spain.

The ideal candidate holds a life sciences degree (RN or Pharmacist preferred) and has contracts/budgeting negotiation experience, fluent in English and Spanish, with strong communication and