Clinical Trials Regulatory Officer - Regulatory Maintenance, Poland

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries.

• Bachelor's degree in Life Sciences, Pharmacy, Health Sciences, or a related field.
• 2 - 3 years experience in clinical trial regulatory affairs, clinical research, or regulatory submissions.
• Knowledge of GCP, clinical trial regulations, and regulatory submission processes.
• Strong organizational, communication, and stakeholder management skills.
• Ability to manage multiple priorities while maintaining accuracy and quality.

• Prepare and review regulatory documents for clinical trial submissions.
• Act as Clinical Trial Regulatory Manager (CTRM) on straightforward projects and support complex projects under senior guidance.
• Review scientific and regulatory documentation, conduct gap analyses, and provide recommendations to stakeholders.
• Prepare, compile, and maintain clinical trial submission dossiers in accordance with regulatory requirements.
• Provide regulatory guidance and strategic input to internal teams and external clients.
• Support local, regional, and global clinical trial submissions, including European centralized submissions where applicable.
• Ensure project deliverables are completed within scope, budget, and agreed timelines.
• Maintain high quality standards across all regulatory deliverables.
• Ensure accurate maintenance of systems, databases, tracking tools, and project documentation in line with SOPs.
• Participate in project and system audits as required.
• Perform additional duties as assigned by the Line Manager.

IQVIA maintains a zero tolerance policy for candidate fraud. All information and credentials submitted must be truthful and complete. False statements or omissions during recruitment will result in disqualification or termination in accordance with law.