Director of Global Regulatory Affairs Operations
vor 1 Woche
Job Summary
CSL Vifor is seeking a highly skilled and experienced professional to lead our Central Services Group (CSG). As the Director of Global Regulatory Affairs Operations, you will be responsible for building and managing a global team that prioritizes, plans, prepares, and coordinates all submissions related to our product portfolio.
Key Responsibilities
- Lead the global CSG regulatory group, responsible for prioritizing, planning, preparing, and coordinating all submissions related to the CSL Vifor, Seqirus, and Behring product portfolio.
- Supervise the centralized execution of administrative activities for the whole GRA department, including legalization, translation, and registration samples.
- Oversee the performance of several vendors for all above-mentioned activities, including performance management, resources monitoring, and turnover mitigation plans.
Requirements
- Advanced degree in Life Science or Business with a postgraduate qualification.
- 15+ years' experience in the pharmaceutical industry and Global Regulatory Affairs (CMC, Labeling, Regions, Operations).
- Experience in dossier preparation for core countries and international markets, regulatory affairs processes, and compliance matters.
- Experience with the Veeva RIM Suite is appreciated.
- 10+ years' leadership experience with global regulatory teams, ideally in building high-performing, diverse, and global teams located on various time zones.
About CSL Vifor
CSL Vifor is a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases. Our treatments offer promise for people in more than 100 countries living with conditions in the immunology, hematology, cardiovascular, and metabolic therapeutic areas.
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