Fraser Dove International is partnering exclusively with a pioneering biotechnology organisation operating in Italy, committed to advancing innovative therapies to address unmet medical needs.
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Our client is seeking a strategic leader to drive CMC regulatory activities and guide product development across the lifecycle.Your objectives:Develop and execute robust CMC regulatory strategies that support clinical development and commercial readinessEnsure timely, high‐quality regulatory submissions and approvals across global marketsStrengthen cross‐functional collaboration and regulatory compliance to support innovation and product lifecycle managementWhat you will do:Lead CMC regulatory strategy for clinical and commercial stage products, including preparation of dossier sections and risk assessmentsCollaborate with regulatory authorities such as the European Medicines Agency (EMA) and Food and Drug Administration (FDA) to define development pathwaysManage regulatory submissions including Investigational New Drug (IND), Biologics License Application (BLA), Marketing Authorisation Application (MAA), and variationsSupport inspections and regulatory interactions, ensuring compliance of CMC documentationOversee supplier and Contract Development and Manufacturing Organisation (CDMO) regulatory activities and ensure compliance with Good Manufacturing Practice (GMP)Contribute to innovation in development platforms, particularly in gene therapy and advanced therapiesMonitor regulatory changes and assess impact on development and submission strategiesWhat you will bring:8 to 10 years of experience in CMC regulatory affairs within the biopharmaceutical industryProven experience delivering regulatory strategies and submissions across clinical and commercial stagesExperience engaging with regulatory authorities such as EMA and FDAStrong leadership and stakeholder management capabilitiesDeep understanding of GMP, quality systems, and regulatory complianceBachelor of Science (BSc) in a relevant scientific disciplineDoctor of Philosophy (PhD) or equivalent postgraduate qualification is desirableThis job description in no way states or implies that these are the only duties to be performed by the employee(s) incumbent in this position. xrdztoy
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