Aicha Otmani
Senior Director Regulatory Affairs Cmc @Olema Oncology
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WORK HISTORY
Senior Director Regulatory Affairs Cmc @Olema Oncology
San Francisco, CA, US
EDUCATION
Toulouse INP
MS Chemical Engineering
Université de Mostaganem
Bachelor of Science - BS, Industrial Chemistry
Ecole Nationale Supérieure des Ingénieurs en Arts Chimiques et Technologiques
Ph.D., Chemical Engineering
SKILLS
ABOUT AICHA OTMANI
A strong regulatory affairs professional with diversified and well balanced experience in pharmaceutical industry. In-depth understanding and application of drug development, manufacturing and global regulatory filings and product lifecycle management. Ability to leverage acquired technical experience within various pharmaceutical disciplines to influence dynamic and efficient global regulatory strategiesExpertise includes:• Health authorities interactions (FDA, EMA, PMDA, Health Canada and various European Health Agencies)• Regulatory filing i.e, New and Abbreviated New Drug Applications (NDA/ANDA)• Regulatory lifecycle management of several marketed products• Chemistry Manufacturing and Control (CMC) updates and post approval changes • Change control review, assessment and approval • Thorough knowledge of cGMP, ICH, FDA regulations and guidelines• Design Of Experiment (DOE) and data analysis• Excellent management, communication, collaboration and organization skills• Excellent interpersonal skills and ability to prioritize multiple tasks• Excellent documentation and record keeping skills• Advanced computer skills (Microsoft Project, Word, Excel and Power Point)• Strong attention to details• Multilingual (English/ French/ Arabic)Specialties: Regulatory Affairs Certification (RAC)- Since 2008
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