Regulatory Affairs Specialist

Jobtailor; Deutschland; Remote; EUR 42.000 - 56.000; Vollzeit

Zusammenfassung

Jobtailor is seeking a Regulatory Affairs professional to manage EU CTR submissions and CTIS coordination across multiple regions. You will prepare and review CTA packages, liaise with sponsors and CROs, and ensure timely regulatory submissions in line with guidelines and timelines.

The role requires 2–3 years of clinical research experience in CRO/Pharma, strong English skills, and the ability to work in Romania. Prior sponsor-facing and CTIS experience are assets.

Qualifikationen

• Minimum of 2-3 years of clinical research experience in CRO or Pharma regulatory affairs required
• Experience in initial CTA is essential
• Experience in a sponsor facing role is an asset
• Hands-on experience preparing, reviewing, and submitting regulatory documentation
• Excellent knowledge of EU regional / national regulatory guidelines
• Fluency in English with excellent oral and written skills; additional languages are an asset
• Must be legally able to work in Romania

Aufgaben

• Prepare and submit Part I and/or Part II applications under the EU CTR and other applications
• Ensure regulatory documentation complies with applicable regulations and guidelines and contractual timelines
• 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

Kenntnisse

Regulatory affairs experience

CTA preparation

EU regulatory guidelines

Fluency in English

Project leadership

Ausbildung

Bachelor's degree in a scientific discipline

Tools

Regulatory Intelligence Database

Patient Information Sheet

Informed Consent Form

Jobbeschreibung

• 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