Regulatory Affairs Manager
CurrentLead and manage the Regulatory Affairs Department at Procos S.p.A., ensuring efficient coordination and communication with the Regulatory Affairs Department of the parent Company, CBC Co., Ltd. in Japan. This involves overseeing departmental operations, setting strategic priorities, and ensuring alignment with corporate objectives.Direct collaborative efforts with multiple departments at Procos S.p.A. (Research & Development, Business Development, Production, Quality Unit, Marketing & Sales) to spearhead new company projects. These projects include the development and regulatory submission of NCEs, clinical phase APIs, and generic APIs. My role encompasses project planning, resource allocation, risk management, and timeline adherence from project inception through to successful registration.Act as the primary point of contact for regulatory Health Authorities, both within and outside the EU. This involves managing regulatory submissions, addressing inquiries, and ensuring compliance with global regulatory standards. I have developed extensive and solid experience with Health Authorities, including the FDA, Health Canada, EMA, MHRA, PMDA, among others.Provide comprehensive support to Procos S.p.A. Customers for drug product registration submissions and lifecycle management. This includes offering strategic advice, preparing documentation, and ensuring that Customer submissions meet all regulatory requirements and timelines.
