Delivery & Operations Lead, IQVIA Regulatory Intelligence

Responsibilities:

- Lead and manage multi-regional team in the following areas
- Monitor new, revised or emerging regulatory requirements from a global to a local level
- Notify teams and decision makers with regulatory information to enable them to refine strategies and better manage potential risks
- Support requests from cross functional departments in providing regulatory intelligence
- Lead the content QC for the regulatory affairs content as per defined QMS procedures to ensure production of high-quality regulatory intelligence
Proactively scope, lead and successfully complete content development projects by:
o    Prioritize, scope and drive content improvement/enhancement projects to identify the relevant regulatory content
o    Contribute to the content identification and requirements and the content creation as well as supporting the QC of the content prior to launch.  
o    Work in collaboration with the technical team to design and plan editorial processes and tools to maximize the delivery and quality to regulatory intelligence
o    Develop a data gathering and escalation method to capture and communicate regulatory information and trends
o    Act as the Reg Intel Lead on the organization’s cross-functional teams with new initiatives focus on changes to internal processes, policies and standards based on emerging regulatory intelligence information or in development of new product features, content modules or services
•    Proactively engage with the team members, across direct line and dotted line of reporting, and bring the best of their performance by
o    Effective and result oriented goals and managing performance 
o    Mentoring, coaching and sharing subject matter expertise with others to elevate our capabilities to deliver world-class solutions for clients.

Qualifications:
• Bachelor's Degree
• Proven experience and tenures working in Regulatory Technology or Regulatory Intelligence within Life Sciences (Preferably consultancy or industry)
• Proven experience in managing and leading large teams of Subject Matter Experts
• Knowledge of quality management within Life Sciences
• In-depth knowledge of regulatory requirements related to regulatory procedures and pathways, submission content, dossier requirements for EU, US and key markets globally
• Demonstrated ability to manage and drive project contributions in a timely manner 
• Experience speaking and presenting to executives and leading business change
• In-depth knowledge of IT systems used with regulatory, safety, clinical and quality (validated systems)
• Experience in project and program management with creating roadmaps for the implementation of large-scale regulatory programs
• Business understanding/Commercial acumen
• Ability to create strong working relationships across the organization: Collaborating with cross-functional teams including technology, PMO, regulatory, quality, clinical affairs and others
• Self-motivated, enthusiastic and hard-working
• Strong analytical, organizational and problem-solving skills

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.