Regulatory & Start-Up Specialist, Spain – Portuguese Fluent

Precision For Medicine; Madrid; Presencial; EUR 45.000 - 65.000; Jornada completa

Descripción de la vacante

Precision for Medicine in Spain is seeking a Regulatory and Start Up Specialist to lead site activation and regulatory submissions in the Spanish market. You will coordinate with CA/EC, manage budgets, and ensure compliance with local regulations while translating key documents and maintaining TMF readiness.

The ideal candidate has a life sciences background (RN or Pharmacy helpful), strong English and Portuguese language skills, and experience in contracts and budgeting negotiation within CRO

Formación

• Bachelor’s degree in life sciences or RN; Pharmacy/Pharmacist background beneficial.
• Experience with contracts and budgeting negotiation; regulatory submissions.
• Fluency in English and Portuguese.

Responsabilidades

• Ensure site activation readiness within the assigned country/sites, mitigating risks.
• Prepare Clinical Trial Applications and submission dossiers for authorities.
• Interact with CA/EC and provide updates to regulatory leads.
• Maintain project plans, trackers, and regulatory intelligence tools.
• Coordinate translations and country/site start-up plans.
• Negotiate study budgets and investigator contracts when needed.
• Stay updated on local trial laws and ensure regulatory compliance.
• Maintain TMF readiness and inspection preparedness.

Conocimientos

Regulatory submissions

Contracts & budgeting negotiation

Communication

Organization

Educación

Bachelor's degree in life sciences or related field

RN or equivalent

Pharmacy/ Pharmacist experience (beneficial)

Descripción del empleo

Precision for Medicine in Spain is seeking a Regulatory and Start Up Specialist to lead site activation and regulatory submissions in the Spanish market. You will coordinate with CA/EC, manage budgets, and ensure compliance with local regulations while translating key documents and maintaining TMF readiness.

The ideal candidate has a life sciences background (RN or Pharmacy helpful), strong English and Portuguese language skills, and experience in contracts and budgeting negotiation within CRO