Regulatory Project Manager

1 day ago


Reading, Reading, United Kingdom Iqvia Full time
Job Description

We are seeking a highly experienced Associate Regulatory Project Director to lead our worldwide Regulatory Submissions delivery team within IQVIA Translations. This team is responsible for the development and harmonization of the Regulatory Submissions Process. The successful candidate will have extensive experience working with QRDs, CTDs, SmPC, PIL, and other regulatory materials for EMA, SwissMedic, FDA, and the rest of the world.

Key Responsibilities
  • Lead a team of Regulatory submission Team Leaders under their remit and ensure the whole team meets and exceeds their monthly and yearly goals and objectives.
  • Implement processes to improve efficiency and ensure high-quality deliverables for all Regulatory Submissions projects.
  • Represent IQVIA Translations in strategic RFP processes as needed for Regulatory Submissions projects.
  • Liaise with clients to establish methodologies and assess and agree 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 teams' projects to effectively anticipate and prevent issues.
  • Ensure that teams accurately and timely complete project finances including quoting and budgeting.
  • Understand and adhere to the Quality Management System.
Requirements
  • A 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.
  • Excellent attention to detail to ensure that high-quality standards are maintained.


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