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Akram Hatem

Position: Director, Regulatory Affairs Europe (non-EU), Middle East and Africa
Categories: Speakers 2022

Through the years within different organizations, I have learned how it is hard to bring the right people together, give them support to work as one team towards a common goal and find creative solutions for the unusual business challenges. Being a Regional Regulatory Affairs Director for EEMEA region based in Monheim, Germany, I restructured the hub and was able to manage several turnarounds the region, making sure that RA systems were updated, as well as improving the submission and approval timelines and archiving situations. In addition, I was excited to take part in developing countries closing models, putting together the Central Transfer Plan (CTP) and lead the global MAH concept development. As well, prepare the separation plans for the major 50 countries globally with colleagues across multiple regions (US, EEA, APAC, LATAM and EEMA) and time zones in a genuine, professional as well as friendly attitude. With all my combined education and experiences, I find it very suitable to a global management position in the Regulatory Affairs and R&D field.

Through the years within different organizations, I have learned how it is hard to bring the right people together, give them support to work as one team towards a common goal and find creative solutions for the unusual business challenges. Being a Regional Regulatory Affairs Director for EEMEA region based in Monheim, Germany, I restructured the hub and was able to manage several turnarounds the region, making sure that RA systems were updated, as well as improving the submission and approval timelines and archiving situations. In addition, I was excited to take part in developing countries closing models, putting together the Central Transfer Plan (CTP) and lead the global MAH concept development. As well, prepare the separation plans for the major 50 countries globally with colleagues across multiple regions (US, EEA, APAC, LATAM and EEMA) and time zones in a genuine, professional as well as friendly attitude. With all my combined education and experiences, I find it very suitable to a global management position in the Regulatory Affairs and R&D field.