The Associate Director – Regulatory Submissionsis 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.
• Ensure that high quality is maintained for all projects through QA checks and comprehensive CAPA plans
• Contribute to develop a continues 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 IQVIA Lean Manager to be able to effectively lead/Collaborate in IQVIA Lean initiatives
• When assigned, ensures 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 Associated 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 to manage competing priorities and changing demands.
• Excellent problem solving and analytical skills
• Ability to follow instructions and work independently whilst 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
IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. Learn more at
