EU Regulatory Affairs Specialist — CTIS & CTAs Expert

Indero (formerly Innovaderm); Warszawa; On-site; PLN 120,000 - 180,000; Full time

Benefits offered by this job

Permanent full-time position

Flexible schedule

Vacation

Home-based position

Ongoing learning and development

Job summary

Indero is seeking a Regulatory Affairs Specialist to lead the preparation and submission of regulatory documents across EU CTIS submissions and other global dossiers. The role involves coordinating timelines, reviewing external submissions, and serving as the regulatory liaison for sponsors and cross-functional teams.

You will ensure compliance with EU CTR and local requirements, maintain regulatory intelligence, and contribute to start-up activities for clinical trials on a global scale.

Qualifications

• Bachelor's degree in a scientific discipline.
• 2–3 years of clinical research experience with Romania regulatory affairs.
• Experience in initial CTA submissions is essential.
• Sponsor-facing experience is an asset.
• CTIS experience is an asset.
• Hands-on regulatory document preparation, review and submission.

Responsibilities

• Prepare regulatory documents, CTA packages and submissions in assigned countries.
• Coordinate regulatory timelines for CTIS submissions in EU, APAC and North America.
• Review documents prepared externally to ensure quality before submission.
• Act as point of contact for sponsors and project teams on regulatory submissions.
• Prepare or review country-specific Patient Information Sheets / Informed Consent forms.
• Prepare or review study regulatory forms templates and translations.
• Provide regulatory guidance on local requirements and EU submission strategy.
• Maintain knowledge of EU CTR and local requirements; manage regulatory intelligence.
• Participate in kick-off meetings, audits and other project meetings.

Skills

Regulatory affairs

CTIS submissions

GCP / ICH

English fluency

Regulatory coordination

Project management

Attention to detail

Education

Bachelor's degree in a scientific discipline

Tools

CTIS platform

Regulatory document management

Job description

Indero is seeking a Regulatory Affairs Specialist to lead the preparation and submission of regulatory documents across EU CTIS submissions and other global dossiers. The role involves coordinating timelines, reviewing external submissions, and serving as the regulatory liaison for sponsors and cross-functional teams.

You will ensure compliance with EU CTR and local requirements, maintain regulatory intelligence, and contribute to start-up activities for clinical trials on a global scale.