Regulatory Start-Up Lead (Spain) — Contracts & Budgets

Precision Medicine Group; United States; Remote; USD 69,000 - 104,000; Full time

Job summary

Precision for Medicine is seeking a Regulatory and Start Up Specialist based in Spain to lead site activation, regulatory submissions, and budget negotiations. The role emphasizes contracts, timelines, and cross-functional collaboration across regulatory, clinical operations, and site contracts teams.

Ideal candidates will have regulatory/start-up experience in CRO or pharma, strong English/Spanish fluency, and a background in life sciences.

Qualifications

• Bachelor’s degree in life sciences or related field (ideally scientific/healthcare).
• RN or equivalent combination of education, training, and experience is acceptable.
• Pharmacist qualification or experience would be highly beneficial.

Responsibilities

• Prepare Clinical Trial Application Forms and submission dossiers to authorities and ethics committees per local requirements.
• Interact with CA/EC for study purposes and respond to submissions.
• Maintain regulatory trackers, plans, and intelligence tools and update leadership.
• Coordinate with site CRA to ensure alignment and site activation readiness.
• Translate and coordinate translations for regulatory documents as needed.
• Ensure TMF readiness and maintain documents per plans.

Skills

Regulatory submissions

Contract negotiations

Communication skills

Organizational skills

Education

Bachelor’s degree in life sciences

Registered Nurse (RN)

Pharmacist qualification beneficial

Job description

Precision for Medicine is seeking a Regulatory and Start Up Specialist based in Spain to lead site activation, regulatory submissions, and budget negotiations. The role emphasizes contracts, timelines, and cross-functional collaboration across regulatory, clinical operations, and site contracts teams.

Ideal candidates will have regulatory/start-up experience in CRO or pharma, strong English/Spanish fluency, and a background in life sciences.