Regulatory Affairs Specialist (Spain) - Remote

Overview

Innovaderm is looking to hire a Regulatory Affairs Specialist responsible for ensuring compliance with regulations and guidelines for clinical trial submissions.

In Short

• Preparation of regulatory documents and submissions
• Coordination of regulatory timelines for projects
• Review of documents from subcontractors
• Point of contact for Sponsors and project teams
• Preparation of Patient Information Sheets/Informed Consent forms
• Management of translation requests
• Regulatory support to project teams
• Maintain knowledge of EU CTR and local requirements
• Maintain regulatory intelligence database
• Participation in project-related meetings

Requirements

• Bachelor's degree in a scientific discipline
• 2-3 years of clinical research experience in Spain regulatory affairs
• Experience in initial CTA
• Experience in a sponsor facing role is an asset
• Hands-on experience with regulatory documentation

Benefits

• Permanent full-time position
• Flexible schedule
• Vacation
• Home-based position
• Ongoing learning and development