Regulatory Affairs Specialist

• Prepare and submit Part I and/or Part II applications under the EU CTR and other applications created within or outside the company
• Ensure regulatory documentation complies with applicable regulations and guidelines and contractual timelines are met
• Provide leadership for assigned projects regarding regulatory activities leading to clinical-trial start-up
• Prepare regulatory documents, CTA packages, and submissions in assigned countries
• Coordinate regulatory timelines and deadlines for CTIS submissions, including oversight of EU, APAC, and North America submissions
• Review regulatory documents and submissions prepared by subcontractors, partner CROs, and regulatory vendors before CTIS submission
• Act as point of contact for sponsors, subcontractors, and project-management teams regarding study regulatory submissions
• Prepare or review country-specific Patient Information Sheet/Informed Consent Form documents
• Prepare or review study-specific regulatory-form templates
• Manage translation requests with vendors
• Provide regulatory support and advice on local requirements, EU submission strategy, and technical matters
• Maintain knowledge of EU CTR and EU/EEA country-specific requirements
• Maintain the regulatory intelligence database
• Participate in kick-off meetings, audits, and other project-related meetings

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 Romania regulatory affairs is required
• 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
• Excellent knowledge of applicable EU regional / national country regulatory guidelines
• Excellent knowledge of GCP and ICH standards
• Fluency in English with excellent oral and written skills, required
• Additional languages represent an asset
• Excellent organization and communication skills, great attention to detail
• Ability to organize own work, prioritize different assignments, and work under pressure
• Versatile and comfortable in a multitasking environment
• Respect established timelines, expectations, priorities, and objectives
• Must be legally able to work in Romania

Core Competencies

Demonstrates expertise in regulatory affairs with a focus on EU CTR compliance, clinical trial applications, and submission processes. Proficient in managing regulatory documentation and timelines while ensuring adherence to GCP and ICH standards.

Highest-signal resume keywords

• Regulatory Affairs Experience
• Clinical Trial Application (CTA) Preparation
• Knowledge of EU Regulatory Guidelines
• Fluency in English
• Project Leadership

Hard Skills

• Regulatory Documentation Preparation
• Clinical Research Experience
• CTIS Submission
• GCP Knowledge
• ICH Standards Knowledge

Soft Skills

• Excellent Communication Skills
• Attention to Detail
• Organizational Skills
• Ability to Work Under Pressure
• Multitasking Ability

Industry Keywords

• EU CTR
• CRO
• Pharma
• Romania Regulatory Affairs
• Sponsor Facing Role

Tools & Technologies

• Regulatory Intelligence Database
• Patient Information Sheet
• Informed Consent Form