IQVIA Decentralized Clinical Trials (DCT) department is looking for a Regulatory Director with Clinical Trials experience in Europe. To succeed in this position, you should bring previous experience in advising in clinical trials regulatory strategy, interacting regulatory authorities or in clinical trials regulatory compliance. Ideally, also a good understanding of the challenges and opportunities in Decentralized Clinical Trials.

LOCATION: Europe, home based

This is an individual contributor role

Main functions:

• Builds regulatory strategy for IQVIA’s DCT model and engages with regional and national regulatory bodies across Europe (initially) and possibly on a global basis
• Collaborates with the IQVIA Data privacy group to present IQVIA’s DCT compliance model to regulatory bodies and other authorities,
• Supports responses to audits and inspections of DCT, including questions related to the use of technology and the definition of roles within IQVIA DCT model
• Regulatory Intelligence: Maintains awareness and knowledge of new developments within the DCT area, collates, disseminates to - and analyses information for - key stakeholders
• Represents IQVIA on industry committees and working groups with the ability to develop and influence directions and work plans; builds consensus of opinion in these groups and delivers outcomes to industry and with regulators to promote DCT awareness and acceptance
• Actively supports clients’ Regulatory Affairs representatives in interactions with inspectors or national regulatory authorities
• Provides European and global support to advise on DCT implementation strategies for new clinical trials
• May lead/chair a session on Regulatory compliance for DCT or related topics at conferences; writes white papers on DCT regulatory trends and developments
• Communicates an inspiring vision of compliance in DCT and helps others understand and value their role in it

Requirements:

• Degree in Lifesciences or related discipline
• Minimum of 8 years experience in Clinical Trials or clinical development regulatory strategy and advisory
• GCP expertise and experience in audits or inspections
• Previous experience in interactions with authorities (formal and informal discussions)
• Preferably possesses experience in DCT and the associated regulatory compliance challenges
• Advanced negotiation and influencing skills with the aim to identify and resolve issues
• High degree of professionalism in challenging interactions
• Ability to guide and train staff
• Ability to deliver effective presentations to a broad audience
• Ability to work effectively with senior management, remaining motivated and enthusiastic in times of change and other pressure situations
• Fluency in English and one other EU language – French, German, Dutch, Spanish, etc.

At IQVIA, we believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. The advanced analytics, technology solutions and contract research services we provide to the life sciences industry are made possible by our 70,000+ employees around the world who apply their insight, curiosity and intellectual courage every step of the way. Learn more at jobs.iqvia.com.