Who we are looking forPurposeThe Global Regulatory Lead contributes to the Company's success by managing the Corporate R&D Pipeline (projects in R&D Development) by providing regulatory guidance to the R&D Global Core Team as well as other non-R&D functions, as needed.
Main Responsibilities1) Contributes to company success with collaboration from Therapeutic Area (TA) head2) Accountable for global/regional regulatory strategies for new and existing products by leading the Global Regulatory Team (GRT) for assigned projects3) Participates in OMNIS Development Core Teams 4) Leads according to established best practices5) Manages and leads the preparation and review of regulatory applications, reports, and correspondence in a manner that ensures timeliness, accuracy, comprehensiveness, and compliance with internal and external regulatory standards6) When required, act as single point of regulatory contact during inspections from health authorities7) Manages pre-approval and post approval activities, as needed and in agreement within the GRT8) Maintains relationships with the health authorities, developing in-depth knowledge of relevant regulations and requirements9) Provides as needed support to IMDD, Affiliates, and Partners for prioritized issues and topics10) Maintains close relationships with R&D functions and Therapeutic areas; i.e., participates in and manage core team relationships or represent GRT to TAM or XRC etcExperience RequiredAt least ten years of experience within Regulatory Affairs of which at least five in the global contextEducationUniversity degree in a scientific discipline, such as Chemistry, Pharmacy, Chemistry and Pharmaceutical Technology, Human Medicine, Biological Science, BiotechnologyLanguagesWritten and spoken EnglishTechnical SkillsKnowledge of the drug development process, of drug regulations, regulatory procedures and drug development guidanceSoft SkillsEmotional and social intelligenceLeadership and social influencePlanning and organizational skillsStrategic thinkingWhat we offerYou would join a dynamic, fast-growing, challenging and friendly environment.In Chiesi we firmly believe that our people are our most valuable asset, that is why we invest in continuous training, learning and development.
Therefore, we strive to continuously promote and satisfy development needs, paying particular attention to the quality of our working environment and to collective well-being.We want our people to come to work happy every day, and we know how important it is to find the right work-life balance in order to be able to give our best.
That is why we offer flexible working approach, remote working, support in the relocation process, tax assistance service for foreign colleagues and many other people-care services.