Regulatory Affairs Specialist-Romania
Core
Prepare and submit Part I/II regulatory applications under EU CTR to ensure compliance and meet timelines for clinical trial startups.
Role type
Regulatory Affairs Specialist (Clinical Trials)
Builds
Regulatory submissions for clinical trials in EU, APAC, and North America
Domain
Clinical Research / Dermatology & Rheumatology (via careerplan.io/jobs/15-003-9A-276-regulatory-affairs-specialist-romania)
Required skills
EU CTR regulations, GCP, ICH standards, CTA package preparation, CTIS submissions, regulatory document review, translation management
Preferred skills
Sponsor-facing experience, knowledge of Poland/Spain/Germany/France/Netherlands regulations, additional languages
Technologies
CTIS, CTA packages
Responsibilities
Prepare regulatory documents and CTA packages; coordinate timelines for CTIS submissions; review subcontractor documents; advise project teams on local requirements; manage translation requests; maintain regulatory intelligence database.
Seniority
Mid-level, hands-on IC