Spain Regulatory & Start-Up Specialist — Contracts & Budget

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

Descripción de la vacante

Precision for Medicine is seeking a Regulatory and Start Up Specialist based in Madrid, Spain. You will drive site activation readiness, prepare submission dossiers, and coordinate regulatory interactions with authorities and ethics committees.

Fluency in English and Portuguese is required, with contracts and budgeting negotiation experience for Spain being essential. The role involves maintaining start-up plans, coordinating translations, and supporting budget negotiations within a CRO/pharma

Formación

• Bachelor’s degree in life sciences or nursing; pharmacy degree is beneficial.
• Experience with regulatory submissions and contracts/budget negotiation.
• Fluency in English and Portuguese.

Responsabilidades

• Ensure timely site activation readiness and mitigate risks.
• Prepare CTA forms and submission dossiers for authorities/ethics.
• Interact with CA/EC and provide timely responses.
• Maintain regulatory trackers and start-up plans.
• Coordinate translations of essential documents.
• Negotiate study budgets and investigator contracts as needed.
• Maintain TMF readiness and site activation data.

Educación

Life sciences degree

RN (nursing)

Pharmacy degree (beneficial)

Herramientas

MS Excel

Regulatory databases

Descripción del empleo

Precision for Medicine is seeking a Regulatory and Start Up Specialist based in Madrid, Spain. You will drive site activation readiness, prepare submission dossiers, and coordinate regulatory interactions with authorities and ethics committees.

Fluency in English and Portuguese is required, with contracts and budgeting negotiation experience for Spain being essential. The role involves maintaining start-up plans, coordinating translations, and supporting budget negotiations within a CRO/pharma