PpPhilogen S.p.A. is a biotechnology company listed on the Milan Stock Exchange and a leader in the development of innovative anti-tumor therapies. As we expand our clinical development activities, we are strengthening our Regulatory Affairs organization. /p pWe are currently seeking a highly motivated, experienced bSenior Director, Regulatory Affairs /b to support the development and execution of regulatory strategies across our pipeline. The successful candidate will report to the Head of Regulatory Affairs and will play a pivotal role in guiding regulatory planning and delivering key submissions to support the company’s products. /p pThe role requires a strong regulatory background, the ability to manage complex submissions, and close collaboration with cross-functional teams across the organization. /p h3Key Responsibilities /h3 ul liDevelop and contribute to regulatory strategies supporting clinical development programs and product lifecycle management. /li liLead and manage activities related to the preparation, submission, and approval of regulatory dossiers with global regulatory authorities (including bEMA and FDA /b). /li liCoordinate and prepare regulatory submissions such as bINDs, CTAs, MAAs, variations, and scientific advice procedures /b. /li liEnsure regulatory documentation is accurate, complete, and compliant with applicable regulatory requirements and company objectives. /li liAct as a key regulatory contact for project teams, providing strategic regulatory input during product development. /li liInteract with regulatory authorities and support regulatory meetings and communications. /li liReview and contribute to regulatory sections of clinical and development documentation. /li liEnsure regulatory compliance throughout the development lifecycle, including maintenance activities for approved products. /li liSupport the preparation and management of regulatory documentation, including beCTD submissions /b. /li liMaintain up-to-date knowledge of global regulatory requirements, guidelines, and industry best practices. /li liContribute to internal regulatory processes, documentation, and SOP development. /li liCollaborate closely with Clinical, Quality, CMC, and other internal departments to ensure alignment of regulatory strategies. /li /ul h3Requirements /h3 ul liUniversity degree in Life Sciences, Pharmacy, or a related scientific discipline. /li libAt least 10 years of experience in Regulatory Affairs /b within the pharmaceutical or biotechnology industry. /li liStrong experience with bglobal regulatory submissions and regulatory lifecycle management /b. /li liSolid understanding of bICH guidelines and global regulatory frameworks /b, particularly bEMA and FDA /b. /li liExperience with beCTD submissions /b and regulatory documentation management. /li liAbility to work cross-functionally and manage multiple projects in a dynamic environment. /li liStrong written and verbal communication skills. /li liFluent in English (written and spoken). /li /ul h3We offer /h3 pA contract and salary proportional to the experience of the successful candidate. /p h3Job location: /h3 pWe invite interested candidates to submit their applications expressly authorizing the processing of personal data in accordance with Legislative Decree 196/2003. Our recruitment adheres to the provisions of Legislative Decree 198/2006, and we welcome applications from candidates of any gender orientation or expression, sexual orientation, age, ethnicity, or religious belief. /p /p #J-18808-Ljbffr