Fresenius Kabi SwissBioSim GmbH

Provide global leadership regarding management of submission CMC related documents and CMC regulatory data for Biosimilars As Business partner to the Biosimilar CMC team develops, supervises and manages the CMC regulatory activities and CMC submission strategy of Biosimilar dossiers and submissions that best serve the biosimilars business needs Ensure that Biosimilars Business uses Document and Submission Management System and liaise with the GRA Regulatory Informatics & Submission Management group Translate CMC data in regulatory CMC positioning in order to create a comprehensive story line and CMC dossier Act as RA CMC lead for late stage projects Manage assigned project members of the Regulatory Affairs CMC team Act as a lead for preparation and finalization of Quality regulatory documents which form the basis of worldwide submissions such as clinical trials applications (from Phase I) where required, parts of initial marketing as required Provide Regulatory Affairs CMC expertise on Biosimilars for assigned development projects Manage the completion of the relevant Quality documentation to allow timely submissions for the assigned products / countries Manage, plan and finalize responses to Quality questions from Authorities Prepare briefing books and provide support at Regulatory agencies meetings on quality issues Mentor Regulatory professionals in all aspects of Regulatory Affairs CMC Biologics in support of product development Provide support at Regulatory agencies meetings on quality issues Ensure that the input in quality development incorporates the outcome of consultations and negotiations with Regulatory Authorities Ensure that for every manufacturing Change Control Proposal (CCP) the implications have been considered and justify the implementation Carry out regulatory review of study protocols and reports, as well as other relevant regulatory documents intended for the product documentation platform or to local submission. Liaise with authors and data generating functions (as applicable) or data providers Keep up-to-date with the current regulatory environment and Quality area, coordinate timely implementation of any changes or new relevant laws or guidance; provide comments on new laws on behalf of FK-SBS through the appropriate procedure, as applicable Represent Regulatory Affairs CMC on the project teams for the assigned projects Serve as an interface between company functions as appropriate May support business development opportunities / due diligence