Regulatory Affairs Specialist

hace 7 días


Madrid, Madrid, España Iqvia A tiempo completo

Regulatory Affairs Role Overview

As a Regulatory Affairs Specialist at IQVIA, you will play a critical role in supporting clinical trial and marketing authorization activities for both internal and external clients. Your expertise will be instrumental in preparing and reviewing regulatory submissions to ensure compliance with regulatory requirements.

Key Responsibilities

  • Independently provides regulatory support for complex projects, including technical writing and project management.
  • Acts as a Regulatory Team Leader on complex projects, guiding junior colleagues and ensuring high-quality deliverables.
  • Establishes and maintains relationships with clients, presenting regulatory information and lessons learned.
  • Manages project budgets, ensuring revenue recognition and challenging discrepancies as necessary.
  • Develops and implements regulatory SOPs, proposing revisions and reviewing existing documents.

Requirements

  • Bachelor's or Master's Degree in Life Science or related field.
  • Comprehensive regulatory expertise and strong software skills, including MS Office applications.
  • Excellent negotiation and issue-resolution skills, with ability to adapt to changing circumstances.

About IQVIA

IQVIA is a global leader in clinical research services, commercial insights, and healthcare intelligence. We accelerate the development and commercialization of innovative medical treatments to improve patient outcomes worldwide.



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