Regulatory and Start Up Specialist (Portuguese speaker)

Overview

Support regulatory submissions and site start-up activities for clinical trials in Spain. The role requires contracts and budget negotiation experience for Spain and fluency in Portuguese and English.

What you'll do

• Deliver timely, quality site activation readiness across assigned sites.
• Prepare clinical trial applications and submission dossiers.
• 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 translations for site activation and IMP release.
• Support site contract and study budget negotiations.
• Maintain knowledge of local clinical trial laws and regulations.

What you'll need

• Bachelor’s degree in life sciences or a related field, or Registered Nurse qualification or equivalent education, training, and experience.
• Experience with regulatory submissions.
• Experience negotiating contracts and budgets.
• Previous regulatory or start-up experience in a CRO, pharmaceutical, or biotechnology company, or equivalent relevant experience.
• Fluency in English and Portuguese.
• Strong communication and organizational skills.
• Experience with computerized information systems, spreadsheets, word processing, and email.

Nice to have

• Pharmacy qualification or pharmacist work experience.
• Regulatory and site start-up experience, including feasibility, contract negotiations, and authority or ethics submissions.
• Experience with milestone tracking tools.
• Advanced medical or life sciences degree or RAC certification.

Details

• Location: Spain.
• Work mode: Remote.