Associate Director, Translations Regulatory Submissions Project Management

.Associate Director, Regulatory Submissions Project Management page is loaded Associate Director, Regulatory Submissions Project Management Apply locations Reading, Berkshire, United Kingdom Madrid, Spain time type Full time posted on Posted Yesterday job requisition id R1418404 The Associate Director – Regulatory Submissions is responsible to lead a worldwide Regulatory Submissions delivery team within IQVIA Translations.This team is in charge of the development and harmonization of the Regulatory Submissions Process. The Associate Director – Regulatory Submissions has experience working with QRDs, CTDs, SmPC, PIL and any other regulatory materials for EMA, SwissMedic, FDA and rest of the world.
- Lead Regulatory submission Team Leaders under his/her remit and ensure the whole team meets and exceed 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 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 to 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, analysing 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 complete 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 collaborates to Quality and Compliance team to ensure best standards are reach