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 objectivesLead and implement processes to improve efficiency and to ensure high quality deliverables for all Regulatory Submissions projectsCoordinate with colleagues in other departments to develop and expand on existing workflows and offeringsRepresent IQVIA Translations in strategic RFP processes as needed for Regulatory Submissions projectsAct as main point of contact for internal / external clients and manage any escalations or issues that may arise within the teamLiaise with the client to establish methodologies and to assess and agree project parameters and requirementsPrepare and implement smooth on-boarding plans for future new clientsCoordinate 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 expertsMonitor and manage the status of the teams' projects to effectively anticipate and prevent issuesEnsure that the team accurately and timely complete project finances including quoting and budgetingUnderstand and adhere to the Quality Management SystemComply with relevant and applicable IQVIA procedures and SOPsMaintain and update SOPs when applicableWork with Team Leads to help in the training and development of junior staffClosely 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 plansContribute 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 PracticesGet trained as IQVIA Lean Manager to be able to effectively lead / Collaborate in IQVIA Lean initiativesWhen 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 industryExperience in leading a team of Project Managers within Regulatory SubmissionsBachelor's degree, ideally in a linguistic, business or scientific fieldFluency in English is essential, an additional language would be advantageousExperience in Russian Regulatory submissions will be highly consideredExcellent written / verbal communication skillsExcellent attention to detail to ensure that high quality standards are maintainedAbility to meet strict deadlines and to manage competing priorities and changing demands.Excellent problem solving and analytical skillsAbility to follow instructions and work independently whilst using own initiative.Demonstration of advanced IT skillsExperience working with technical files, TMS and CAT tools, experience working with XTRF and / or MemoQ would be highly advantageousAbility to establish and maintain effective working relationships with colleagues, managers and clientsIQVIA 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
#J-18808-Ljbffr
