Remote Regulatory Affairs Specialist — EU CTIS Expert

Indero (formerly Innovaderm); Warszawa; On-site; PLN 120,000 - 160,000; Full time

Benefits offered by this job

Permanent full-time position

Flexible schedule

Vacation

Home-based position

Ongoing learning and development

Job summary

Indero, formerly Innovaderm, seeks a Regulatory Affairs Specialist to oversee regulatory submissions and CTIS coordination across EU countries, APAC, and North America. You will lead preparation, review, and timely submission of documents, with a focus on quality and regulatory compliance.

The role requires a Bachelor's degree in a scientific field and hands-on experience in regulatory affairs, including CTIS. Fluency in English and strong communication skills are essential.

Qualifications

• Bachelor's degree in a scientific discipline.

Responsibilities

• Preparation of regulatory documents, CTA packages, and submissions in assigned countries to ensure high quality standards.
• Coordination of regulatory timelines and deadlines for CTIS submissions across EU/APAC/North America.
• Review of regulatory documents and submissions prepared outside the company for quality before CTIS submission.
• Point of contact for Sponsors and subcontractors for all study regulatory submissions.
• Preparation or review of country specific Patient Information Sheet/Informed Consent forms.

Job description

Indero, formerly Innovaderm, seeks a Regulatory Affairs Specialist to oversee regulatory submissions and CTIS coordination across EU countries, APAC, and North America. You will lead preparation, review, and timely submission of documents, with a focus on quality and regulatory compliance.

The role requires a Bachelor's degree in a scientific field and hands-on experience in regulatory affairs, including CTIS. Fluency in English and strong communication skills are essential.