CMC REGULATORY AFFAIRS MANAGER

Fondazione Telethon is one of Italy's leading non-profit organisations. Our mission is to invest in the best scientific research to arrive at a cure for rare genetic diseases. For these diseases, precisely because of their rarity, there is often no research, no therapies, no cure. We want to change this state of affairs because every person is important to us. Fondazione Telethon ETS is currently searching for a CMC Regulatory Affairs Manager. The candidate will work in the Research and Development Department on specific Telethon’s projects in late development / marketing phase (Strimvelis, Telethon003) as well as Telethon’s Institutes’ (TIGET and TIGEM) projects in early / mid development phase. The candidate will have the following responsibilities: Support the CMC Regulatory Team: Help the team implement and manage CMC regulatory strategies for gene therapy projects, ensuring everything aligns with regulatory requirements. Contribute to the regulatory strategy for clinical trials and commercial products by preparing CMC sections of regulatory dossiers, performing gap analyses, and helping address any missing information. Assist with Regulatory Authorities Inspections: Provide support during Regulatory Authorities inspections by ensuring that all necessary CMC regulatory information for investigational and commercial products is organized and compliant. Support in the preparation and documentation of regulatory submissions: Assist in preparing and managing CMC aspects of regulatory documents for assigned projects, including managing CMC-related requests for Orphan Drug Designation (ODD), Scientific Advice, and Pediatric Investigation Plans (PIP). Contribute to initial regulatory submissions for clinical trials and commercial products, and support the regulatory process throughout the product lifecycle, including submissions for changes to marketing authorizations (MAA / BLA) and investigational product dossiers (IMPD / IND). Monitor Regulatory framework: Stay on top of regulatory updates and contribute to the team’s strategy to ensure we always meet the latest standards, especially for orphan drugs, advanced therapies (ATMP), GMP, and compliance. Collaborate with CMC and Quality Assurance Teams: Ensure compliance of GMP documents to regulatory commitments and provide support for batch release process (review / approval deviations, status of approval of change, etc.). Work in collaboration with the Quality Assurance and CMC teams to evaluate any events affecting product quality, such as deviations or out-of-specification results, and help manage change controls performing the regulatory impact assessment. Minimum Requirements: Bachelor’s or Master’s degree in Pharmacy, Biotechnology, Chemistry, Biology, Pharmaceutical Sciences, or a related life sciences field. Previous experience (ideally, 5-7 years of experience) in Regulatory Affairs, GMP, or CMC in the pharmaceutical or biotech industry. Previous experience with Cell & Gene Therapies. Excellent English oral and written communication skills. Ability to work autonomously and prioritize workflow. Demonstrated analytical, problem resolution and communication skills. Strong communication and organizational skills to manage regulatory documents and collaborate with global regulatory bodies. Attention to detail, with the ability to manage multiple tasks in a regulated environment. RAL and type of contract will be commensurate with seniority. We will only consider candidates who will attach their Resume when applying. We thank you in advance for expressing your interest in the Organization. We inform you that, due to the huge amount of applications received, we will be able to provide feedback only to those who will be contacted from Fondazione Telethon. #J-18808-Ljbffr