Director of Global Regulatory Affairs Operations
Vor 6 Tagen
We are seeking a highly experienced and skilled professional to lead our Central Services Group (CSG) as the Director of Global Regulatory Affairs Operations. This is a critical role that will play a pivotal part in shaping our ability to deliver high-quality submissions efficiently and timely across the globe.
Key Responsibilities- Team Leadership
- Build, develop, and manage a global CSG team by identifying and retaining top talent, conducting interviews, and fostering a positive and productive work environment.
- Lead the global CSG regulatory group, responsible for prioritizing, planning, preparing, and coordinating all submissions related to our product portfolio.
- Process Optimization
- Continuously seek efficiency gains by exploring and leveraging new ways of working and operating.
- Supervise the centralized execution of administrative activities for the whole Global Regulatory Affairs department.
- Vendor Management
- Oversee the performance of several vendors for administrative activities, including performance management, resource monitoring, and turnover mitigation.
- Collaboration and Communication
- Collaborate with senior leaders in CMC, Regions, and Labeling to understand their requirements and objectives.
- Establish forums to discuss and enhance CSG processes.
- Education
- Advanced degree in Life Science or Business with a postgraduate qualification.
- Experience
- 15+ years' experience in the pharmaceutical industry and Global Regulatory Affairs.
- Experience in dossier preparation for core countries and international markets.
- Experience with the Veeva RIM Suite is appreciated.
- Leadership Experience
- 10+ years' leadership experience with global regulatory teams.
- Proven track record of building high-performing, diverse, and global teams.
- Skills and Qualities
- High level of flexibility, pragmatism, and solution-oriented working style.
- Ability to link long-range visions to daily work.
- Proven success in partnering and influencing across a matrix environment.
- Fluency in English.
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.
Why Join UsWe encourage you to make your well-being a priority. It's essential and so are you. Learn more about how we care at CSL.
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