Reg Affairs Lead

To perform this job successfully, an individual must demonstrate project management skills and strong expertise.

Essential functions:

• Prepares and reviews regulatory submissions on behalf of clinical research studies and secures marketing authorizations.
• Technical writing to complete regulatory and/or technical documents to ensure complete and high-quality regulatory deliverables.
• Communicates regulatory issues and opportunities to customers.
• Provides strategic regulatory guidance to project teams.

Qualifications: 

• Degree in Lifescience
• 2 or more years in a Project Management role leading similar sized efforts.
•  4 or more years working in a Regulatory role assisting in the developing regulatory submission documents.
• Experience in regulatory requirements for an asset transfer .
• Direct experience with program management of regulatory affairs projects.
• Effective communication skills.
• Strong leadership skills.
• Good decision maker. 

LI-MS8

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 67,000+ employees around the world who apply their insight, curiosity and intellectual courage every step of the way. Learn more at jobs.iqvia.com.