Regulatory Affairs Specialist - Romania

Indero is seeking a Regulatory Affairs Specialist responsible for preparing and submitting regulatory documents for clinical trials, ensuring compliance with EU and other regional regulations, and providing regulatory leadership for clinical trial start-up.

Location: Remote (Romania)

Responsibilities

• Preparation of regulatory documents, CTA packages, and submissions in assigned countries to ensure high quality standards
• Coordination of regulatory timelines and deadlines for all assigned projects planned for CTIS submissions. Includes oversight of EU (mainly), APAC, and North America submissions.
• Review of regulatory documents and submissions created outside of the company by subcontractors (eg, partner CROs, regulatory vendors) to ensure high quality standards before submission to CTIS
• Point of contact for Sponsors and subcontractors/project management teams for all aspects related to study regulatory submissions
• Preparation or review of country specific Patient Information Sheet/Informed Consent form documents.
• Preparation or review of study-specific templates of regulatory forms.
• Manages translation requests with vendor.
• Regulatory support and advice to project teams and key internal/external customers on local requirements and EU submission strategy and technical expertise
• Maintain high level knowledge about EU CTR and EU/EEA countries local requirements in the area of company interest.
• Maintain the regulatory intelligence database
• Participation in Kick-off meetings, audits, and other project related meetings according to the company / client needs

Requirements

• Bachelor's degree (or equivalent) in a scientific discipline
• Minimum of 2-3 years of clinical research experience (in CRO or Pharma) working in Poland regulatory affairs
• Experience in initial CTA is essential
• Experience in a sponsor facing role is an asset
• Previous experience with CTIS is an asset
• Hands-on experience preparing, reviewing, and submitting regulatory documentations

Benefits

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