Regulatory Affairs Specialist
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
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