Regulatory Affairs Specialist - Spain

Indero is seeking a Regulatory Affairs Specialist to manage regulatory submissions and compliance for clinical trials across multiple regions, including EU, APAC, and North America.

Location: Remote (EU)

Responsibilities

• Preparation of regulatory documents, CTA packages, and submissions in assigned countries.
• Coordination of regulatory timelines and deadlines for CTIS submissions.
• Review of regulatory documents and submissions created outside of the company.
• Point of contact for Sponsors and subcontractors for regulatory submissions.
• Preparation or review of country-specific Patient Information Sheet/Informed Consent forms.
• Preparation or review of study-specific regulatory forms.
• Manage translation requests with vendors.
• Provide regulatory support and advice to project teams.
• Maintain knowledge of EU CTR and local requirements.
• Maintain the regulatory intelligence database.
• Participate in kick-off meetings, audits, and project meetings.

Requirements

• Bachelor's degree in a scientific discipline.
• Minimum of 2-3 years of clinical research experience in Poland regulatory affairs.
• Experience in initial CTA.
• Experience with CTIS is an asset.
• Hands-on experience preparing, reviewing, and submitting regulatory documentation.

Benefits

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