Senior Manager, Regulatory CMC Biosimilars (m/f/d)

24.11.2020

Daten dieser Anzeige

Job-ID: 018494783
Senior Manager, Regulatory CMC Biosimilars (m/f/d)

Fresenius Kabi

Germany

https://relaxx.center/r/9908b0038a2349fdbbe783cf7c0aaf6c?pid=206612&mpid=66612&prid=23793&tid=30

As Business partner to the Biosimilar R&D team manages the CMC regulatory activities and CMC submission strategy of Biosimilar dossiers and submissions that best serve the biosimilars business needs and ensure compliance with the regulatory systems. Execute the CMC RA Strategy for assigned projects. Manages submission CMC related documents for assigned Biosimilars. Translate CMC data in regulatory CMC positioning, to create a comprehensive story line. Act as Regulatory Affairs CMC lead for early stage projects. Manage, prepare and finalize Quality regulatory documents which form the basis of worldwide submissions for clinical trials applications (from Phase I onwards), BLA/MAA initial applications and Life Cycle Management. Manage the completion of the relevant Quality regulatory documents to allow timely submissions for the assigned products/countries and responses to questions from Authorities. Prepare briefing books and provide support at Regulatory agencies meetings on Module 3 topics. Ensure that the input in quality development incorporates the outcome of consultations and negotiations with Regulatory Authorities. Carry out regulatory review of Change Control Proposal (CCPs), CMC protocols and reports, as well as other relevant CMC documents intended Keep up-to-date with the current regulatory environment and Quality area. Ensure regulatory filing systems are maintained and up to date. Deputy Regulatory Affairs CMC Director where needed. Lead CMC Regulatory sub-teams on assigned projects. Serve as an interface between company functions as appropriate. Carry out any other tasks as required by the function to achieve its mission and objectives.

About Fresenius / CAREER WITH A PURPOSE / Fresenius Kabi is a global healthcare company that specializes in lifesaving medicines and technologies for infusion, transfusion and clinical nutrition. Our products and services are used to help care for critically and chronically ill patients. Senior Manager, Regulatory CMC Biosimilars (m/f/d)  With our corporate philosophy of «caring for life», we are committed to putting essential medicines and technologies in the hands of people who help patients and to finding the best answers to the challenges they face. In the field of biosimilars, we develop products with a focus on autoimmune diseases and oncology. Fresenius Kabi SwissBioSim GmbH is specialized in biosimilar medicines and consists of an experienced team of employees located in the Geneva region of Switzerland. As in all our ranges, Fresenius Kabi is committed to provide high-quality and affordable products for the therapy and care of critically and chronically ill patients. Your assignments Your assignments As Business partner to the Biosimilar R&D team manages the CMC regulatory activities and CMC submission strategy of Biosimilar dossiers and submissions that best serve the biosimilars business needs and ensure compliance with the regulatory systems. Execute the CMC RA Strategy for assigned projects. Manages submission CMC related documents for assigned Biosimilars. Translate CMC data in regulatory CMC positioning, to create a comprehensive story line. Act as Regulatory Affairs CMC lead for early stage projects. Manage, prepare and finalize Quality regulatory documents which form the basis of worldwide submissions for clinical trials applications (from Phase I onwards), BLA/MAA initial applications and Life Cycle Management. Manage the completion of the relevant Quality regulatory documents to allow timely submissions for the assigned products/countries and responses to questions from Authorities. Prepare briefing books and provide support at Regulatory agencies meetings on Module 3 topics. Ensure that the input in quality development incorporates the outcome of consultations and negotiations with Regulatory Authorities. Carry out regulatory review of Change Control Proposal (CCPs), CMC protocols and reports, as well as other relevant CMC documents intended Keep up-to-date with the current regulatory environment and Quality area. Ensure regulatory filing systems are maintained and up to date. Deputy Regulatory Affairs CMC Director where needed. Lead CMC Regulatory sub-teams on assigned projects. Serve as an interface between company functions as appropriate. Carry out any other tasks as required by the function to achieve its mission and objectives.  Your profile Your profile Education Degree in a Life Science or related discipline and possible higher degree Work experience At least 5 years Regulatory Affairs CMC experience Experience in managing international or regional regulatory submissions, IND/IMPD or variations Experience in interaction with regulatory agency Experience in biological product development Job-specific competencies & skills Excellent spoken and written English. A second major language would be an advantage. Excellent written and spoken communication skills Excellent interpersonal skills Good organizational and planning skills Attention to details Ability to work in teams Apply now  Share by email  Print this page Your contact Your Contact Karen Ibarra-Gonzalez Fresenius Kabi SwissBioSim GmbH Ref. number: 41158>  fresenius-kabi.de At a glance Career level: Professional Experienced Job category:  Regulatory Affairs / Drug Safety Working condition: Permanent / Full-time Business segment: Fresenius Kabi Location:  Eysins / International Closing date for application:  none - we look forward to your application About Fresenius About Fresenius Over 290,000 people across the globe work at Fresenius to provide better medicine for more people. Our independent business segments Fresenius Medical Care, Fresenius Kabi, Fresenius Helios and Fresenius Vamed offer a wide spectrum of products and services in the health sector. We offer you the opportunity to make a difference with your career - and to become part of our impressive growth story. >  career.fresenius.com >  fresenius.com One of Fresenius' strengths: our corporate culture for "entrepreneurs in an enterprise" where you can quickly take on responsibility. The benefits we offer: Profit-sharing, long-term accounts for your future plans and other benefits which meet individual needs. >  More reasons >  More benefits Fresenius Kabi SwissBioSim GmbH https://files.relaxx.center/kcenter-google-postings/kc-18740/logo_google_kabi.png 2021-01-22T13:41:04.575Z FULL_TIME EUR YEAR null 2020-11-23 Eysins 1262 46.3845552 6.199776

Pharma, Chemie, Med.-/ Biotechnologie

Projekt- und Produktmanagement/ Qualitätsmanagement

Sonstige Branchen

Medizintechnik/ Optik

Angestellter/ Fachkraft

Vollzeit