Specialist, Regulatory Affairs (Poland) - Remote

Overview

Due to ongoing global expansion, Innovaderm is looking to hire a Regulatory Affairs Specialist. In this position, you will be responsible for preparation and submission of part I and/or part II following EU CTR and other applications created within or outside of the company to ensure documentation comply with applicable regulations and guidelines and contractual timelines are met. You will provide leadership for assigned projects regarding all regulatory activities that lead to start up of clinical trials.

In Short

• Preparation of regulatory documents and submissions.
• Coordination of regulatory timelines for CTIS submissions.
• Review of regulatory documents from subcontractors.
• Point of contact for Sponsors and project management teams.
• Preparation or review of Patient Information Sheets.
• Management of translation requests.
• Regulatory support to project teams.
• Maintain knowledge of EU CTR and local requirements.
• Maintain the regulatory intelligence database.
• Participation in project-related meetings.

Requirements

• Bachelor's degree in a scientific discipline.
• 2-3 years of clinical research experience in regulatory affairs.
• Experience in initial CTA is essential.
• Experience in a sponsor facing role is an asset.
• Hands-on experience with regulatory documentation.
• Excellent knowledge of EU regulatory guidelines.
• Fluency in English required.
• Excellent organization and communication skills.
• Ability to prioritize assignments and work under pressure.
• Comfortable in a multitasking environment.

Benefits

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