Requirements: English
Company: JR Italy
Region: Latina , Lazio
Social network you want to login/join with:BSP Pharmaceuticals S.p. A is focused on the development and manufacturing of anticancer drugs with high potency and cytotoxic characteristics for the Pharmaceuticals Industry.BSP has been at the forefront in the fight against cancer since 2006.Innovation is the hallmark of BSP with investments in new technologies and production methods in a high containment plant.We are one of the most important Contract Development and Manufacturing Organizations (CDMOs) for anticancer drugs.The fight against cancer is ours too.We are currently looking for a Regulatory Affairs SpecialistMain activities :Support the monitoring of the site''s regulatory compliance through the implementation, management, and control of the necessary GMP documentation, both internal and provided by clients and suppliers;Implement and manage regulatory document storage databases;Manage technical documentation related to adventitious agents (TSE, Viral Clearance, Allergens, Aflatoxins, GMOs, latex, gluten, conflict materials, etc.);Support clients in registration and post-registration phases through the preparation of dossiers (including in eCTD format);Manage consular paperwork for international registrations, coordinating with external entities (notary, public prosecutor''s office, prefecture, consulates, and consultants) to issue the appropriate legalized documentation;Support the management of MIA maintenance practices for medicine production, preparing paperwork for variations, communications, and authorization/registration for the import of active substances or updating the Site Master File;Process and manage the DMF for active substances production for commercial use.Main requirements:MA degree (in Chemistry, Pharmacy, Biology, etc.);MS degree in Regulatory Affairs is a plus;At least 5 years of experience in similar roles within complex organizations;Knowledge of GMP;Working proficiency in English;At BSP, we believe in an inclusive workplace that fosters bold innovation through collaboration and empowers our people to unleash their full potential. We respect diversity, different backgrounds, and experiences, providing equal opportunities for all.#J-18808-Ljbffr