Regulatory & Start-Up Specialist (Portuguese, Remote)

Precision Medicine Group; España; A distancia; EUR 45.000 - 65.000; Jornada completa

Descripción de la vacante

Precision Medicine Group is seeking a Regulatory and Start Up Specialist based in Spain (remote) who will drive regulatory submissions and site activation activities for clinical trials. Fluency in Portuguese and English is required, with experience in contracts and budgeting negotiations for Spain.

The role collaborates with regulatory leads, start-up teams, and site contracts management to ensure timely approvals, accurate documentation, and robust regulatory intelligence.

Formación

• Bachelor’s degree in life sciences or related field or RN/Pharmacist qualification.
• Experience with regulatory submissions required.
• Experience in contracts and budgeting negotiation for Spain.

Responsabilidades

• Ensure site activation readiness in assigned country/sites on time and with quality.
• Prepare Clinical Trial Applications and submission dossiers per local requirements.
• Interact with regulators and ethics committees; respond to queries.
• Maintain project plans, trackers, and regulatory intelligence tools.
• Coordinate translations and ensure country/site start-up documentation is complete.
• Negotiate study budgets and investigator contracts under guidance as needed.

Conocimientos

Portuguese language

English language

Regulatory submissions

Contract negotiations

Educación

Bachelor’s degree in life sciences or related field

RN or PharmD qualification

Advanced regulatory science / RAC

Descripción del empleo

Precision Medicine Group is seeking a Regulatory and Start Up Specialist based in Spain (remote) who will drive regulatory submissions and site activation activities for clinical trials. Fluency in Portuguese and English is required, with experience in contracts and budgeting negotiations for Spain.

The role collaborates with regulatory leads, start-up teams, and site contracts management to ensure timely approvals, accurate documentation, and robust regulatory intelligence.