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Director Regulatory Affairs CMC (m/f/d)
Eysins (Schweiz)
Aktualität: 20.05.2023


20.05.2023, Fresenius Kabi
Eysins (Schweiz)
Director Regulatory Affairs CMC (m/f/d)
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
Sionals, enabling them to find the right answer to the challenge they face. Fresenius Kabi is a driver of healthcare for the coming decade. We truly live diversity and value different backgrounds and motivations. Around the world, all of us are committed to our shared endeavor: caring for life. Degree in a Life Science or related discipline and possible higher degree Work experience: At least 10 years pharmaceutical experience of which at least 8 years in international regulatory with focus on CMC in Biologics Experience in managing a full initial marketing application submission or IMPD/INDs Experience in preparation and coordination of regulatory strategy plans Experience in interaction with regulatory agency in agency meetings for the major agencies (EMA/FDA) Experience in analytics or drug substance process development for new biological entities Experience in development of new biologicals or biosimilars Job-specific competencies & skills: Excellent spoken and written English. A second European language would be an advantage. Excellent written and spoken communication skills Excellent interpersonal skills Understanding of Regulatory Affairs contribution to Pharma business Good organizational and planning skills Ability to think strategically Ability to lead and work in teams



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