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Director of Regulatory Submissions Operations

2 months ago

Reading, Reading, United Kingdom IQVIA Full time

Job Summary:

The Associate Director – Regulatory Submissions is a key leadership role within IQVIA Translations, responsible for leading a worldwide Regulatory Submissions delivery team. This team is responsible for the development and harmonization of the Regulatory Submissions Process, working with 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 their remit and ensure the whole team meets and exceeds their monthly and yearly goals and objectives.
  • Lead and implement processes to improve efficiency and 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.
  • Liaise with the client to establish methodologies and assess and agree project parameters and requirements.
  • Prepare and implement smooth on-boarding plans for future new clients.
  • Coordinate and communicate with interviewers and recruiters for the purpose of conducting debriefing interviews, analyzing results, and making recommendations for improvements.
  • 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.
  • Comply with relevant and applicable IQVIA procedures and SOPs.
  • Maintain and update SOPs when applicable.
  • Work with Team Leads to help in the training and development of junior staff.
  • Closely collaborate with the Quality and Compliance team to ensure best standards are reached.
  • Ensure that high-quality is maintained for all projects through QA checks and comprehensive CAPA plans.
  • Contribute to develop a continuous improvement culture where productivity and quality standards should be raised year by year through the usage of state-of-the-art technologies and IQVIA Lean Best Practices.
  • Get trained as an IQVIA Lean Manager to be able to effectively lead/Collaborate in IQVIA Lean initiatives.
  • When assigned, ensure the team is closely aligned to collaborate and meet priorities defined by project PIC (Principal in Charge).

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.
  • Excellent written/verbal communication skills.
  • Excellent attention to detail to ensure that high-quality standards are maintained.
  • Ability to meet strict deadlines and manage competing priorities and changing demands.
  • Excellent problem-solving and analytical skills.
  • Ability to follow instructions and work independently while using own initiative.
  • Demonstration of advanced IT skills.
  • Experience working with technical files, TMS, and CAT tools; experience working with XTRF and/or MemoQ would be highly advantageous.
  • Ability to establish and maintain effective working relationships with colleagues, managers, and clients.