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

• Deliver timely, quality 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 trial master file documentation.
• Review essential documents and coordinate document translations for site activation and IMP release.
• Coordinate with clinical, feasibility, project management, regulatory, and site contracts teams.
• Support site feasibility, budget negotiations, investigator contract execution, and pre-study site visits.

What you'll need

• Bachelor’s degree in life sciences or a related field, or RN or equivalent education, training, and experience.
• Experience negotiating contracts and study budgets.
• Previous regulatory or start-up experience in a CRO, pharmaceutical, or biotech setting.
• Strong communication and organizational skills.
• Experience with electronic 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 Master’s in Regulatory Science.

Details

• Location: Spain.
• Work mode: Remote.