Regulatory Affairs Specialist supports with Lifecycle maintenance and Marketing Authorisation Transfers. Provides operational support to ensure the wellbeing of clinical research subjects and the best possible project outcomes.

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.

Requirements:

• Degree in Lifescience or related discipline.
• At least  2 years relevant experience.
• Good understanding of the Research and Development process (Chemistry, Manufacturing & Controls, Preclinical and Clinical), laws and related guidelines, as appropriate.
• Ability to establish and maintain effective working relationships with coworkers, managers and clients.
• Ability to work on several projects, with direction from senior staff as appropriate.

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.