Senior Regulatory Affairs Specialist-Poland

Indero is seeking a Senior Regulatory Affairs Specialist to provide leadership for assigned projects regarding all regulatory activities that lead to the startup of clinical trials. In this role, you will oversee global and multinational complex clinical trial submissions while acting as a key sponsor-facing regulatory lead.

Key responsibilities

• Coordinate regulatory timelines and lead global submissions for complex clinical trials.
• Provide regulatory support, advice, and technical expertise to project teams.
• Prepare and review core and country-specific submission packages to ensure compliance.
• Perform regulatory review of essential documents and authorize regulatory release for investigational products.
• Mentor junior team members and support regulatory country intelligence activities.

Requirements

• Bachelor’s degree in a scientific discipline, with Regulatory Affairs experience being an asset.
• 3-5 years of experience in clinical regulatory affairs within the pharmaceutical, biotechnology, or CRO industry.
• Strong understanding of global regulatory requirements, including EU-CTR and GCP guidelines.
• Fluency in English with excellent oral and written communication skills.
• Ability to prioritize assignments and work effectively in a multitasking environment.

What we offer

• Permanent full-time position with a flexible work schedule.
• Comprehensive benefits package including medical, dental, and vision coverage.
• Opportunities for ongoing learning and professional development.
• A stimulating work environment focused on integrity, commitment, and teamwork.