pBSP Pharmaceuticals S.p. A is focused on the development and manufacturing of anticancer drugs with high potency and cytotoxitc characteristics for the Pharmaceuticals Industry. /p pBSP has been at the forefront in the fight agains cancer since 2006. /p pInnovation is the hallmark of BSP with investments in new technologies and production methods in a high containment plant. /p pWe are one of the most important Contract Development and Manufacturing Organization (CDMOs) for anticancer drugs. /p pCome for Science. Stay for Purpose. /p h3We are currently looking for a Regulatory Affairs Specialist /h3 h3Main activities : /h3 ul liSupport 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; /li liImplement and manage regulatory document storage databases; /li liSupport clients in the registration and post-registration phases through the preparation of dossiers (also in eCTD format); /li liManage 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; /li liSupport 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; /li /ul h3Main requirements: /h3 ul liMA degree (CTF/Chemistry, Pharmacy, Biology..); /li liMS degree in Regulatory Affairs is considered a plus; /li li3 years of experience in similar roles in complex organizations; /li liKnowledge of GMP; /li liEnglish working knowledge; /li /ul pActual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is : /p p35-40k /p pAt 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. /p #J-18808-Ljbffr
📌 Regulatory Affairs Specialist (Latina)
🏢 BSP Pharmaceuticals
📍 Latina
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