Director of Regulatory Submissions

hace 4 semanas


Madrid, Madrid, España Iqvia A tiempo completo
Lead Regulatory Submissions Team

The Associate Director Regulatory Submissions is a key member of the IQVIA Translations team, responsible for leading a worldwide Regulatory Submissions delivery team. This team is responsible for developing and harmonizing the Regulatory Submissions Process, ensuring high-quality deliverables for all Regulatory Submissions projects.

Key Responsibilities
  • Lead a team of Regulatory Submission Team Leaders to achieve monthly and yearly goals and objectives.
  • 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 and external clients, managing escalations or issues that may arise within the team.
  • Liaise with clients to establish methodologies and assess and agree project parameters and requirements.
  • Prepare and implement smooth on-boarding plans for future new clients.
  • Collaborate with Vendor Managers to develop an extensive network of Regulatory Submissions linguists and subject matter experts.
  • Monitor and manage the status of the team's projects to effectively anticipate and prevent issues.
  • Ensure that the team accurately and timely completes project finances, including quoting and budgeting.
Requirements
  • Strong leadership and project management skills.
  • Excellent communication and interpersonal skills.
  • Ability to work in a fast-paced environment and prioritize multiple tasks.
  • Knowledge of regulatory submissions processes and procedures.
  • Experience working with QRDs, CTDs, SmPC, PIL, and other regulatory materials.
  • Ability to represent IQVIA Translations in strategic RFP processes.


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