Regulatory Submissions Project Manager Lead

hace 7 días


Madrid, Madrid, España Iqvia A tiempo completo

Job Summary: We are seeking a highly experienced Regulatory Submissions Project Manager Lead to join our team at IQVIA. This role will lead a worldwide delivery team responsible for the development and harmonization of the Regulatory Submissions Process.

About the Role: The Associate Director – Regulatory Submissions has experience working with QRDs, CTDs, SmPC, PIL, and any other regulatory materials for EMA, SwissMedic, FDA, and the rest of the world.

Key Responsibilities:

  • Lead Regulatory submission Team Leaders under his/her remit and ensure the whole team meets and exceeds their monthly and yearly goals and objectives.
  • Lead and implement processes to improve efficiency and to ensure high-quality deliverables for all Regulatory Submissions projects.
  • Coordinate with colleagues in other departments to develop and expand on existing workflows and offerings.
  • Represent IQVIA Translations in strategic RFP processes as needed for Regulatory Submissions projects.
  • Act as the main point of contact for internal/external clients and manage any escalations or issues that may arise within the team.

Requirements:

  • Minimum of 5 years of experience specializing in Regulatory Submissions as a Manager, Team Leader, Director, or Associate Director in the Life Sciences Language Services industry.
  • Experience in leading a team of Project Managers within Regulatory Submissions.
  • Bachelor's degree, ideally in a linguistic, business, or scientific field.
  • Fluency in English is essential; an additional language would be advantageous.
  • Experience in Russian Regulatory submissions will be highly considered.

Estimated Salary Range: $110,000 - $140,000 per year

IQVIA Benefits: As a global leader in advanced analytics, technology solutions, and clinical research services, we offer a comprehensive benefits package, including medical, dental, and vision insurance, retirement savings plan, paid time off, and opportunities for professional growth and development.



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