Informationen zur Anzeige:
Director Regulatory Affairs CMC (m/f/d)
Eysins (Schweiz)
Aktualität: 04.06.2023
Anzeigeninhalt:
04.06.2023, 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
Berufsfeld
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