Regulatory Project Director

1 month ago

Reading, Reading, United Kingdom Iqvia Full time
Job Title: Associate Regulatory Project Director

The Associate Regulatory Project Director is a key member of our team, responsible for leading the development and harmonization of the Regulatory Submissions Process. This role requires a strong understanding of QRDs, CTDs, SmPC, PIL, and other regulatory materials for EMA, SwissMedic, FDA, and the rest of the world.

Key Responsibilities:
  • Lead Regulatory submission Team Leaders under your 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.
  • Represent IQVIA Translations in strategic RFP processes as needed for Regulatory Submissions projects.
  • Liaise with the client to establish methodologies and to assess and agree on project parameters and requirements.
  • Collaborate with Vendor Managers to develop an extensive network of Regulatory Submissions linguists and subject matter experts.
  • Monitor and manage the status of the teams' projects to effectively anticipate and prevent issues.
  • Ensure that the team accurately and timely completes project finances including quoting and budgeting.
  • Understand and adhere to the Quality Management System.
  • Work with Team Leads to help in the training and development of junior staff.
  • Closely collaborate with the Quality and Compliance team to ensure the best standards are reached.
  • Ensure that high quality is maintained for all projects through QA checks and comprehensive CAPA plans.
  • Contribute to developing a continuous improvement culture where productivity and quality standards are raised year by year through the usage of state-of-the-art technologies and IQVIA Lean Best Practices.
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.

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