Regulatory Affairs Manager
Fresenius Kabi
Dec 2010 - Current (15 years 6 months)
Responsible for the overall management of the Regulatory Affairs Department and all regulatory activities to support and grow the business in line with the company goals. Lead and manage the development of regulatory strategies to support the registration of new products, line extensions, major variations, and lifecycle management. Provide strategic contribution to the RA team, anticipating what regulatory needs to contribute to achieve business objectives. Manage the HA/BoH interface throughout the development and lifecycle of a product, developing a long-term and positive relationship characterized by Integrity, Quality, Compliance, and Leadership. Face before the MOH authorities. Lead the regulatory activities to support different commer
