/ 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.
Head of Regulatory Affairs CMC (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.
Fresenius Kabi SwissBiosim has also been certified as an Equal Pay Employer.
Represent Fresenius-Kabi SwissBioSim in international forums and congresses pertaining Regulatory Affairs CMC matters 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 and ensure compliance with the regulatory systems Provides global leadership regarding management of submission CMC related documents and CMC regulatory data for Biosimilars Represents the Regulatory Affairs CMC department at cross functional or intercompany committees Owns the overall Regulatory Affairs CMC strategy for Biosimilar projects Translate CMC data in regulatory CMC positioning in order to create a comprehensive story line and CMC dossier May act as RA CMC lead for development projects Manage, supervise and develop the 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) and initial registrations 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 timely finalize responses to Quality questions from Authorities Prepare or oversees preparation of briefing books and provide support at Regulatory agencies meetings on quality issues Mentor Regulatory professionals in all aspects of Regulatory Affairs Biosimilars in support of product development 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 that are either used for submissions or part of submissions. 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 Ensure regulatory filing systems are maintained and up to date. Perform pre-submission Audits of Quality documentation versus the data generated at and activities performed by the manufacturing sites Represent Regulatory Affairs CMC on the project teams for the assigned projects Regulatory Affairs CMC on the steering committees Lead CMC Regulatory sub-teams on assigned projects Serve as an interface between company functions as appropriate Support business development opportunities/due diligence Carry out any other tasks as required by the function to achieve its mission and objectives
Degree in a Life Science or related discipline and possible higher degree
At least 15 years pharmaceutical experience of which at least 10 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 major 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
Apply now Share by email Print this page
Amélie Curchod Fresenius Kabi SwissBioSim GmbH
Ref. number: 52569
At a glance
Career level: Professional Experienced
Job category: Regulatory Affairs / Safety
Working condition: Permanent / Full-time
Business segment: Fresenius Kabi
Location: Eysins / International
Closing date for applications: none - we look forward to your application
Over 300,000 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.
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.
Fresenius Kabi SwissBioSim GmbH https://files.relaxx.center/kcenter-google-postings/kc-18740/logo_google_kabi.png
2022-11-05T07:35:04.503Z FULL_TIME EUR YEAR null