Regulatory Affairs Specialist-Romania
Core
Prepare and submit Part I/II regulatory applications (CTA) for clinical trials in EU/EEA countries, ensuring compliance with EU CTR and local guidelines.
Role type
Regulatory Affairs Specialist (Clinical Trials)
Builds
Regulatory submissions for clinical trial startups
Domain
Clinical Research / Dermatology & Rheumatology (via careerplan.io/jobs/15-003-9A-276-regulatory-affairs-specialist-romania-at-indero)
Required skills
EU CTR knowledge, GCP/ICH standards, CTIS submission, CTA package preparation, regulatory document review, translation management, regulatory intelligence database maintenance
Preferred skills
Sponsor-facing experience, CTIS experience, knowledge of Poland/Spain/Germany/France/Netherlands regulations, additional languages
Technologies
CTIS, EU CTR
Responsibilities
Prepare CTA packages and submissions for assigned countries; Coordinate regulatory timelines for CTIS submissions; Review subcontractor documents; Act as point of contact for sponsors and project teams; Prepare Patient Information Sheets and Informed Consent forms; Manage translation requests; Provide regulatory advice on local requirements and EU strategy; Maintain regulatory intelligence database; Participate in kick-off meetings and audits.
Seniority
Mid-level, hands-on IC