Regulatory Affairs Specialist-Poland

Indero is a world-renowned clinical research leader in dermatology and rheumatology, currently seeking a dedicated Regulatory Affairs Specialist to join our expanding global team. In this role, you will play a pivotal part in ensuring our clinical trial documentation meets rigorous regulatory standards and timelines across international markets.

Key responsibilities

• Prepare and submit high-quality regulatory documents and CTA packages in assigned countries.
• Coordinate regulatory timelines and manage submissions for CTIS, with oversight of EU, APAC, and North American projects.
• Review regulatory submissions prepared by subcontractors to ensure compliance and quality standards.
• Serve as the primary point of contact for sponsors and project management teams regarding regulatory submission activities.
• Provide expert regulatory advice to internal and external stakeholders on EU submission strategies and local requirements.

Requirements

• Bachelor's degree in a scientific discipline.
• Minimum of 2-3 years of clinical research experience in a CRO or pharmaceutical environment.
• Proven experience with initial CTA preparation and submission.
• Excellent knowledge of EU regional regulatory guidelines, GCP, and ICH standards.
• Fluency in English with strong communication and organizational skills.

What we offer

• Permanent full-time position within a collaborative and innovative team.
• Flexible work schedule to support work-life balance.
• Fully remote work environment.
• Opportunities for ongoing professional learning and career development.