Spain-based Regulatory & Start-Up Specialist for Clinical Trials

Precision Medicine Group; Madrid; Presencial; EUR 45.000 - 75.000; Jornada completa

Descripción de la vacante

Precision Medicine Group in Madrid, Spain, is seeking a Regulatory and Start Up Specialist for an on-site role. You will drive site activation, prepare CTAs and submission dossiers, and liaise with authorities and ethics committees to obtain approvals in line with ICH-GCP and local requirements.

The ideal candidate will have CRO/pharma experience, strong budgeting and contract negotiation skills, and fluency in English and Spanish, with Portuguese as a plus.

Formación

• Bachelor’s degree in life sciences or related field; RN or Pharmacist background is advantageous.
• Experience in regulatory submissions to authorities and ethics committees.
• Proven budgeting and contract negotiation experience.
• Background in CRO or pharmaceutical/biotech regulatory/start-up roles.
• Fluent in English and Spanish; Portuguese a plus; strong communication skills.

Responsabilidades

• Deliver site activation readiness for assigned country/sites on time.
• Prepare Clinical Trial Application forms and submission dossiers per local requirements.
• Interact with authorities and ethics committees and manage responses.
• Coordinate with site CRAs and project teams; maintain plans and trackers.
• Translate and coordinate document translations; ensure TMF readiness.
• Keep knowledge of local trial laws and ensure compliance.

Conocimientos

Regulatory affairs

Clinical start-up

Budget negotiation

Contract management

Documentation control

Cross-functional collaboration

Communication skills

Team coordination

Educación

Bachelor's degree in life sciences

Registered Nurse (RN)

Pharmacist qualification

Herramientas

MS Office

eTMF systems

Descripción del empleo

Precision Medicine Group in Madrid, Spain, is seeking a Regulatory and Start Up Specialist for an on-site role. You will drive site activation, prepare CTAs and submission dossiers, and liaise with authorities and ethics committees to obtain approvals in line with ICH-GCP and local requirements.

The ideal candidate will have CRO/pharma experience, strong budgeting and contract negotiation skills, and fluency in English and Spanish, with Portuguese as a plus.