Regulatory Affairs Director for Global Compliance
6 days ago
IQVIA Laboratories is a global leader in drug discovery and development laboratory services, offering a comprehensive suite of central laboratory and specialty biomarker services.
Estimated Salary:$120,000 - $180,000 per year, depending on experience.
Job Description:This leadership-level position will oversee regulatory compliance within the IQVIA Laboratories' Central Laboratories functions, ensuring ongoing adherence to global regulations and standards.
Key Responsibilities:- Evaluate and implement regulatory strategies to ensure compliance with current global requirements, including IVDR and FDA LTD regulations.
- Develop and manage a central repository of regulatory compliance status and documentation.
- Support customer audits and inspections by providing documentation on procedures surrounding regulatory compliance.
- Collaborate with internal stakeholders and third-party providers to assess compliance and provide guidance on solutions.
- At least 10 years of experience in the clinical trial or medical device domain, with a deep understanding of current global regulatory requirements.
- Excellent customer management and relationship-building skills.
- Strong organizational and project management skills, with proficiency in Microsoft Office and LIMS systems.
- Demonstrated knowledge of medical and clinical research terminology, as well as global regulatory requirements for conducting clinical trials in central laboratories.
- Work-Life Balance and positive well-being.
- Continuous career development and growth opportunities.
- Variety of therapeutic areas and collaborative team environment.
- Access to cutting-edge technology and innovative processes.
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