Regulatory & Start-Up Specialist — Spain

Precision for Medicine; Madrid; Presencial; EUR 40.000 - 70.000; Jornada completa

Descripción de la vacante

Precision for Medicine is seeking a Regulatory and Start Up Specialist based in Madrid to drive country/site activation for clinical trials. You will prepare submissions, interact with authorities and ethics committees, and coordinate with regulatory, clinical operations, and contracts teams to ensure timely approvals.

You should have a life sciences degree (or RN/PharmD) and strong English/Spanish skills, with experience in CRO or pharma government submissions.

Formación

• Bachelor's degree in life sciences or RN/PharmD or equivalent.
• Experience with regulatory and site start-up in CRO/pharma settings.
• Strong communication and organizational skills.
• Fluency in English and Spanish; Portuguese a plus.

Responsabilidades

• Ensure timely site activation readiness within assigned country/sites.
• Prepare Clinical Trial Application Forms and submission dossiers per local regulations.
• Interact with regulatory authorities and ethics committees; respond to queries.
• Maintain regulatory trackers and start-up plans; coordinate with cross-functional teams.

Conocimientos

Regulatory submissions

Project coordination

English proficiency

Spanish proficiency

Communication skills

Educación

Bachelor's degree in life sciences or RN or PharmD

Herramientas

eTMF software

Microsoft Office

Descripción del empleo

Precision for Medicine is seeking a Regulatory and Start Up Specialist based in Madrid to drive country/site activation for clinical trials. You will prepare submissions, interact with authorities and ethics committees, and coordinate with regulatory, clinical operations, and contracts teams to ensure timely approvals.

You should have a life sciences degree (or RN/PharmD) and strong English/Spanish skills, with experience in CRO or pharma government submissions.