Regulatory and Start Up Specialist (Portuguese speaker)

Overview

Manage 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 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.
• Coordinate essential document collection, review, translations, and site activation requirements.
• Maintain project plans, trackers, regulatory intelligence tools, and trial master file records.
• Support site feasibility, pre-study site visits, budget negotiations, and investigator contract execution.
• Maintain knowledge of local clinical trial laws and regulations.

What you'll need

• Bachelor's degree in life sciences or a related field, or RN/equivalent education, training, and experience.
• Experience with regulatory submissions.
• Experience negotiating contracts and budgets.
• Fluency in English and Portuguese.
• Previous regulatory or start-up experience in a CRO, pharmaceutical, or biotechnology setting.
• 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.
• Milestone tracking tools experience.
• Advanced medical or life sciences degree, RAC certification, or Master's in Regulatory Science.

Details

• Location: Spain.
• Work mode: Remote.