Regulatory and Start Up Specialist

Overview

Own regulatory submissions and site start-up activities for clinical trials in Spain, including contracts and budget negotiations.

What you'll do

• Coordinate timely, quality-focused site activation readiness and mitigate risks.
• Prepare clinical trial applications and submission dossiers for authorities and ethics committees.
• Interact with competent authorities and ethics committees and manage responses.
• Maintain project plans, trackers, regulatory intelligence tools, and critical-path data.
• Review essential documents and coordinate patient information and informed consent translations.
• Support site feasibility, budget negotiations, investigator contracts, and pre-study site visits.
• Maintain regulatory knowledge, audit readiness, and trial master file documentation.

What you'll need

• Bachelor’s degree in life sciences or a related field, or RN/equivalent education, training, and experience.
• Experience negotiating contracts and budgets.
• Experience as a regulatory or start-up specialist in a CRO, pharmaceutical, or biotechnology setting.
• Strong communication and organizational skills.
• Experience with computerized information systems, spreadsheets, word processing, and email.
• Fluency in English and Spanish.

Nice to have

• Pharmacy qualification or pharmacist work experience.
• Portuguese fluency.
• Regulatory and site start-up experience, including feasibility, contract negotiations, and authority or ethics submissions.
• Advanced medical or life sciences degree, RAC certification, or a Master’s in Regulatory Science.

Details

• Location: Spain.
• Work mode: Remote.