Global Regulatory Lead
4 giorni fa
At Chiesi, we are seeking a highly skilled Global Regulatory Lead to contribute to our company's success by managing the Corporate R&D Pipeline.
Main Responsibilities- Collaborate with the Therapeutic Area head to contribute to company success.
- Develop and lead global/regional regulatory strategies for new and existing products as the leader of the Global Regulatory Team (GRT) for assigned projects.
- Participate in OMNIS Development Core Teams and lead according to established best practices.
- Manage and lead the preparation and review of regulatory applications, reports, and correspondence in a timely, accurate, and comprehensive manner, ensuring compliance with internal and external regulatory standards.
- Act as the single point of regulatory contact during inspections from health authorities when required.
- Manage pre-approval and post-approval activities, as needed, in agreement with the GRT.
- Maintain relationships with health authorities, developing in-depth knowledge of relevant regulations and requirements.
- Provide support to IMDD, Affiliates, and Partners for prioritized issues and topics, as needed.
- Maintain close relationships with R&D functions and Therapeutic areas, participating in and managing core team relationships or representing the GRT to TAM or XRC, etc.
- At least ten years of experience within Regulatory Affairs, with at least five years in the global context.
- University degree in a scientific discipline, such as Chemistry, Pharmacy, Chemistry and Pharmaceutical Technology, Human Medicine, Biological Science, or Biotechnology.
- Strong knowledge of the drug development process, drug regulations, regulatory procedures, and drug development guidance.
- Excellent leadership and social influence skills, emotional and social intelligence, planning and organizational skills, and strategic thinking.
At Chiesi, we believe our people are our most valuable asset, and we invest in continuous training, learning, and development. We strive to promote and satisfy development needs, paying particular attention to the quality of our working environment and collective well-being. We offer a dynamic, fast-growing, challenging, and friendly environment, flexible working approach, remote working, support in the relocation process, tax assistance service for foreign colleagues, and many other people-care services.
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