MBA, General Management @
Drexel University - College of Business and Administration
Over 30 yrs of medical and scientific professional experience with approximately 20 yrs of which in pharma/biotech industry. Global Regulatory Affairs Head, executive leader in large pharmaceutical settings as well as midsize and small biotech. Extensive experience in drug development with a particular focus on strategic regulatory aspects which take into account early research, clinical, commercial, and
Over 30 yrs of medical and scientific professional experience with approximately 20 yrs of which in pharma/biotech industry. Global Regulatory Affairs Head, executive leader in large pharmaceutical settings as well as midsize and small biotech. Extensive experience in drug development with a particular focus on strategic regulatory aspects which take into account early research, clinical, commercial, and postmarketing development leading to optimization of product development path and labeling. Highly successful experience in technically & managerially leading activities and teams to successful biologics (vaccines) and new chemical entities marketing autherization approvals and post marketing activities. Strategic and creative out of the box thinker with a proven track record in leading and guiding complex product development and business strategies to successful outcomes.
Specialties: Drug development leadership experience. Highly successful regulatory negotiator. Extensive global regulatory experience with regional¢ral regulatory bodies (FDA-CBER & CDER, EMA, Japan PMDA etc). Broad&extensive range of drug development experience including Biologics/Vaccines & small molecules. Extensive & diverse global regulatory experience across disciplines including infectious (HIV,HCV &TB), hematology, pulmonary, neurological, metabolic diseases, oncology, genetic disorders & extensive experience in the rare disease (orphan) space.
Vice President, Head Global Regulatory Affairs @ Stem Cells, Cell Therapy in High Unmet Medical Need, Life Threatening and Rare (Orphan) Disorders, including Graft versus Host Disease, Organ Transplants and Ulcerative Colitis, in addition to Cardiac Disorders (Acute Myocardial Infarction) and Neurological Disorders (Ischemic Stroke) From 2013 to Present (2 years) Cleveland/Akron, Ohio AreaVice President, Head of Regulatory Affairs @ Small Molecule Gene Expression Modulation, Rare (Orphan) Diseases (eg. Duchenne Muscular Dystrophy, Cystic Fibrosis, Hemophilia) and Oncology. From 2007 to 2012 (5 years) Senior Director, Global Regulatory Affairs Anti-infectives @ Small Molecule, Infectious Diseases (eg. Tuberclosis (Rare/Orphan), HIV and HCV) From 2004 to 2007 (3 years) Director, Worldwide Regulatory Affairs Vaccines and Biologics @ Director, Worldwide Regulatory Affairs Vaccines and Biologics preceded by positions of increasing responsibilities
Associate Director, Worldwide Regulatory Affairs Vaccines and Biologics
Associate Director, Merck Research Labs, Virus and Cell Biology
Research Fellow, Merck Research Labs, Virus and Cell Biology From 1995 to 2004 (9 years) Assistant Professor, Human Genetics Department @ Assistant Professor, Human Genetics Department
Post Doctoral Fellow, Gene Therapy Program (metabolic disorders - Adenoviral delivery systems) and Genetic Diagnostics (Duchenne, CF etc) From 1991 to 1995 (4 years)
CPD, Professional development @ University of Pennsylvania - The Wharton School From 2003 to 2005 MBA, General Management @ Drexel University - College of Business and Administration From 2000 to 2002 PhD, Molecular Biology and Biomedical sciences @ Eastern Virginia Medical School From 1988 to 1991 MD, Medicine and Surgery @ Alexandria University - Faculty of Medicine From 1977 to 1984 Manal MBA is skilled in: Drug Development, Clinical Development, Pharmaceutical Industry, Regulatory Affairs, Lifesciences, Biotechnology, FDA, Clinical Trials, Regulatory Submissions, Rare Diseases, Orphan Drugs, Pulmonary Diseases, Oncology, Hematology, Metabolic disorders
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