Senior Global Regulatory Affairs Manager Parma

Senior Global Regulatory Affairs Manager
Parma
Emilia Romagna, Parma

Who we are looking forPurposeAs core member of the Global Regulatory Team and strategic partner of the Global Regulatory Leads, the person will leverage 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.

The person will also support the development and/or execution of Global Regulatory Strategy to support the TPP, ensuring its alignment to core product labelling for development/lifecycle management for the assigned region(s).

Main ResponsibilitiesThe person will:Serve as a regional/local regulatory lead and point of contact both internally and with Health Authorities. Contribute (independently or with GRL guidance) to the development of global HA interaction strategy in collaboration with GRT. Be accountable for developing, independently or with GRL guidance, the Health Authority engagement and interaction plans for their assigned products including authoring, leading and moderating preparation meetings. Be accountable for complete and accurate communication/interaction (including tracking) with the relevant HAs for the projects/products in their remit. Lead, independently or with GRL guidance, regulatory subteam to ensure NDA/BLA/ MAA/Extensions/Variations/Renewals filings meet the project timelines, develop core global dossier, and collaborates with other GRT members as appropriate. Ensure that regulatory submission timelines are aligned with program level and company objectives. Contribute to content and reviews for regulated documents Support operational and compliance activities for assigned deliverables, HA contact report (EU & US). Support GMP, GCP, and GPV inspections from health authorities. Be accountable to provide updates on project and submissions status at GRT meetingsBe 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 Affairs EducationMaster's degree in Scientific FieldLanguagesFluent in English Technical SkillsEmerging understanding of clinical development of drugs and/or novel biologics productsUnderstanding 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 VaultDemonstrated ability to handle multiple projects/deliverables simultaneously is preferred. Strong sensitivity for a multicultural/multinational environmentData readiness & competitive intelligenceSoft SkillsStrategic thinkingStress managementTeam workingTime managementPlanning and organizational skillsLocationThe role can be based in Europe, prefarably where an R&D center is located (Italy, UK, France and Sweden)What 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.