Global Regulatory Affairs Manager

3 settimane fa

Parma, Italia Chiesi Group A tempo pieno

Who we are looking forPurposeAs core member of the GRT and strategic partner of the GRL, leverages their regulatory expertise to contribute to the definition and drive the execution of aligned US, EU and/or global regulatory strategy working flexibly within and across regions to ensure the delivery of business objectives.
Supports development and/or execution of Global Regulatory Strategy to support the TPP Ensures alignment of TPP to core product labelling for development/lifecycle management for the assigned region(s).
Main ResponsibilitiesMay serve as a regional/local regulatory lead and point of contact both internally and with Health Authorities.May contribute (independently or with GRL guidance) to the development of global HA interaction strategy in collaboration with GRT.
Accountable for developing, independently or with GRL guidance, the Health Authority engagement and interaction plans for their assigned products incl.
authoring, leading and moderating preparation meetings.
Accountable for complete and accurate communication/interaction (including tracking) with the relevant HAs for the projects/products in their remit.
Leads, independently or with GRL guidance, regulatory subteam to ensure NDA/BLA/ MAA/Extensions/Variations filings meet the project timelines, develop core global dossier, and collaborates with other GRT members as appropriate.
Ensures that regulatory submission timelines are aligned with program level and company objectives.
Contributes to content and reviews for regulated documents  Supports operational and compliance activities for assigned deliverables, HA contact report (EU & US).
Supports GMP, GCP, and GPV inspections from health authorities.
Accountable to provide updates on project and submissions status at GRT meetings.
Accountable to support the GRL on updates to the Affiliates and interactions with IMDD and partners.
Experience RequiredAt least 5-7 years' experience in Regulatory AffairsEducationMaster's degreeLanguagesEnglish fluentTechnical SkillsEmerging understanding of clinical development of drugs and/or novel biologics products Understanding of LCM activities (strategy and executions in major markets eg.
EU/US/CN/JP/CA/AU) Ability to work in electronic document management systems, such as Veeva Vault Demonstrated ability to handle multiple projects/deliverables simultaneously is preferred?.
Strong sensitivity for a multicultural/multinational environment? Data readiness & competitive intelligence? Soft SkillsTeam workingStress managementTime managementPlanning 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.

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