BSP Pharmaceuticals S.p. A is focused on the development and manufacturing of anticancer drugs with high potency and cytotoxitc characteristics for the Pharmaceuticals Industry.
La preghiamo di verificare di possedere il livello di esperienza e le qualifiche adeguate leggendo la panoramica completa di questa possibilità qui sotto.
BSP has been at the forefront in the fight agains cancer since ****.
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 Organization (CDMOs) for anticancer drugs.
Come for Science.
Stay for Purpose.
We are currently looking for a Regulatory Affairs Specialist
Main 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;
Support clients in the registration and post-registration phases through the preparation of dossiers (also in eCTD format);
Manage consular paperwork for international registrations,



coordinating the various external entities (notary, public prosecutor's office, prefecture, consulates and consultants) to issue the appropriate legalized documentation;
Support the management of the MIA maintenance practices for the medicines production, preparing the paperwork for variations, communications, authorization/registration for the import of active substances or updating the Site Master File;
Main requirements:
MA degree (CTF/Chemistry, Pharmacy, Biology..);
MS degree in Regulatory Affairs is considered a plus;
3 years of experience in similar roles in complex organizations;
Knowledge of GMP;
English working knowledge;
Actual compensation will depend on a candidate's education, experience, skills, and geographic location.
xysqume The anticipated wage for this position is :
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At BSP we believe in an inclusive workplace that cultivates bold innovation through collaboration, and empowers our people to unleash their full potential.
We respect the diversity , the different backgrounds and experiences and provide equal opportunity for all.
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📌 Regulatory Affairs Specialist (Latina)
🏢 BSP Pharmaceuticals
📍 Latina