SENIOR GLOBAL COMPLIANCE REGULATORY AFFAIRS MANAGER

PURPOSE OF THE ROLEThe main purpose of this role is to plan, direct, coordinate and oversee quality aspects of activities and duties of Global (GRA) and Local Regulatory Affairs (LRA) teams. This includes also the management and the coordination of quality of regulatory affairs pertinent to third parties. A second purpose of the role is the implementation, enhancement and maintenance of ITF group compliance framework, ensuring adherence to internal procedures as well as to national and international regulations.The role will also be responsible for compliance of computer system validation with applicable references (e.g: 21 CFR part 11, Annex 11, GAMP) and management of non-compliances based on GxP impact evaluation and risk assessment.KEY RESPONSIBILITIESThe key responsibilities of this role are the following:Development, review and implementation of company policies and procedures for activities of GRA and European and extra -European LRA Definition of a Quality Plan for GRA and LRA compliance activitiesMonitor objectives of compliance KPIs for regulatory team and deliver required training for ITF Affiliates and GRA staff.Support global and local regulatory teams with the quality management system in place Oversight and management of applicable Key Performance Indicators pertinent to Regulatory topics and activitiesMonitoring of Regulatory affairs and quality assurance guidelines and regulations for internal updatePlanning and set up of Internal and third parties annual audit planSupport to Global Compliance Director for management of Health Authorities Inspection and for audits received by third parties, acting also as his/her back up in case of leave and/or vacation.Management and performance and/or attendance of third parties’ audits before signature of agreement and delegation of activitiesAssessment of the business’s future ventures to identify possible compliance risksManagement of Deviations/ CAPA/Change until closing and investigation through Root Cause AnalysisReview of the agreement pertaining regulatory affairs activities to ensure the presence of the compliance standardsMaintenance of computer system validation status through the review of the validation documentation and its compliance with applicable reference, the management of change control procedure as well as the periodic review Conducting internal reviews, audits and mock inspections at company and affiliates plantsReviewing marketing materials for compliance with legal requirementsPeriodic evaluation of compliance systems ensuring adequate processes and procedures are in place both for corporate and affiliates. JOB REQUIREMENTSBachelor’s degree in Life Sciences /Sciences/ Biomedical mattersStrong Experience in management of Health Authorities Inspections and Third parties audits At least 8 years of relevant experience in Regulatory Affairs and Quality Assurance area Solid understanding of risk and compliance principles and frameworks.Demonstrated stakeholder engagement experienceAbility to understand the impact of regulatory changes on the businessGood English proficiency (B2 level is required)Use computer tools (PC, E-mail, Office Package, Internet)Soft Skills in management and leadershipFlexibilityInitiative / ProactivityPlanning, organizing, controlling