Remote Regulatory & Start-Up Specialist (Spain/Portugal)

Precision Medicine Group (New York, United States); España; Remote; EUR 45.000 - 65.000; Vollzeit

Benefits dieser Stelle

Remote work

Zusammenfassung

Precision for Medicine in Spain is seeking a Regulatory and Start Up Specialist to lead site activation and regulatory submissions for clinical trials in the region. The role requires strong contracts and budgeting negotiation experience, and collaboration with CA/EC, IRB/EC timelines, and site contracts management.

The ideal candidate will be fluent in English and Portuguese, with CRO/pharma industry experience and excellent communication and organizational skills.

Qualifikationen

• Bachelor's degree in life sciences or related field.
• Fluency in English and Portuguese.
• Experience with contracts and budgeting negotiation.
• Previous regulatory submissions experience.

Aufgaben

• Delivery of site activation readiness within the assigned country/sites and mitigating risks.
• Prepare Clinical Trial Application Forms and submission dossiers for authorities and ethics committees.
• Interact with regulatory authorities and ethics committees; provide timely responses.
• Maintain project plans and regulatory intelligence tools for assigned responsibilities.
• Coordinate translations and ensure TMF readiness and documentation quality.

Kenntnisse

Contracts & budgeting negotiation

Regulatory submissions

English language

Portuguese language

Communication skills

Organizational skills

Ausbildung

Bachelor's degree in life sciences

Registered Nurse (RN) or equivalent

Advanced degree in medical or life sciences

Tools

Excel

Jobbeschreibung

Precision for Medicine in Spain is seeking a Regulatory and Start Up Specialist to lead site activation and regulatory submissions for clinical trials in the region. The role requires strong contracts and budgeting negotiation experience, and collaboration with CA/EC, IRB/EC timelines, and site contracts management.

The ideal candidate will be fluent in English and Portuguese, with CRO/pharma industry experience and excellent communication and organizational skills.