Regulatory Affairs Manager Pisa

Regulatory Affairs Manager
Pisa
Toscana, Pisa

About Us We support pharmaceutical and life science companies throughout the whole product life cycle with tailored Regulatory Affairs and Market Access solutions , according to the needs of national markets in the European Union, the United States and more. We are looking for an experienced and results-driven REGULATORY AFFAIRS MANAGER with expertise in the management and strategic oversight of drug development projects across various stages. Development of regulatory strategies , proven track record of leading cross-functional teams in the preparation of high-quality regulatory dossiers, including IMPD (Investigational Medicinal Product Dossier), CTD (Common Technical Document) modules, IND (Investigational New Drug applications), and NDA (New Drug Applications). Deep understanding of global regulatory requirements, ensuring compliance with FDA, EMA, and other regulatory bodies. Strong client relationship management skills, ensuring that client needs are effectively met throughout the regulatory process. Key responsibilities: Regulatory Strategy Development : Define and implement regulatory strategies for drug development, ensuring alignment with business objectives and regulatory requirements. Dossier Preparation & Submission : Lead the preparation of regulatory submissions, including IMPDs, CTD modules, INDs, and NDAs, ensuring compliance with local and international regulatory standards. Cross-functional Team Leadership : Supervise and collaborate with cross-disciplinary teams (clinical, non-clinical, CMC, etc. ) to ensure efficient project execution and regulatory submission success. Project Management : Oversee drug development timelines and milestones, identifying potential risks and implementing mitigation strategies to ensure successful project completion. Regulatory Compliance : Stay up to date with evolving regulations and guidelines (FDA, EMA, ICH, etc. ), ensuring the development and submission processes meet all applicable requirements. Training and Mentorship : Provide training and guidance to junior regulatory staff, helping them develop their skills in regulatory affairs and submission preparation. With a keen attention to detail, strong communication abilities, and a passion for regulatory affairs, he/she should have successfully contributed to the development and approval of multiple drug products, ensuring that they meet the highest standards of safety, efficacy, and regulatory compliance. The selection respects legislative Decree 198/2006 and is open to candidates of any orientation or expression of gender, sexual orientation, age, ethnicity, and religious belief. This announcement is designed to respect diversity and inclusiveness. J-18808-Ljbffr