Munir Abdullah Email and Phone Number
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Board Member and adviser for healthcare, pharmaceutical, biotechnology and not-for-profit organizations.Board Chairman, Mariam Clinic, Raleigh/Cary NC.Senior Executive with 25 years of significant regulatory, scientific, and drug development expertise.Broad scientific and drug development knowledge for both small molecules and biopharmaceuticals. Strategic regulatory expertise across multiple therapeutic areas. Global regulatory experience for all phases of product life-cycle with extensive FDA interactions and use of innovative regulatory mechanisms to expedite drug development and approval. Dossier planning and preparation of global marketing applications. Successful NDA preparation, submission and reviews with associated labeling and PMR negotiation. Several INDs and NDAs in eCTD format. Successful MAA preparation, submission and reviews. Application maintenance and life cycle management including NDA annual reports, IND DSURs, post-marketing requirements; pediatric plan development and negotiation. Leadership and management roles.
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Chairman Of The BoardMariam Clinic Jan 2020 - PresentRaleigh, North Carolina, United StatesAs Board Chairman responsible for developing strategy, oversee operations and plans to secure funding to continue functioning and for future expansion. Mariam Clinic is a not-for-profit organization which offers free healthcare to the uninsured. The clinic goal is to provide an integrated approach to health and well-being of uninsured individuals regardless of race, gender, or religion.
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Board Member And AdviserHealthcare, Pharmaceuticals, Biotechnology And Not-For-Profit Jan 2018 - PresentRaleigh-Durham, North Carolina Area
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Executive Vice President Regulatory Affairs And Project ManagementCempra Inc. Feb 2016 - Jan 2018Chapel Hill, North CarolinaAs Executive VP led efforts and had accountability for the design and implementation of regulatory strategy to execute on Cempra’s goals of obtaining regulatory approval, launch and commercialization of its antibacterial drugs in development. Served in leadership role in providing regulatory expertise, guidance and management of FDA interactions. Spearheaded preparations for FDA Antimicrobial Drugs Advisory Committee meeting. Responsible for management of Marketing Authorization Applications (MAA) with European Medicines Agency (EMA) and Swissmedic (Swiss Agency for Therapeutic Products). Served as Principal Investigator for Biomedical Advanced Research and Development Authority (BARDA) funded project. Management, supervisory, and mentoring responsibilities for regulatory affairs, regulatory operations and project management personnel. -
Senior Director Regulatory Affairs - Disease Of Developing World & RespiratoryGsk 2003 - Oct 2015Research Triangle Park, NcResponsible for drugs being developed for malaria and tuberculosis (TB) and for allergic rhinitis.Developed global regulatory strategy for registration.Conducted and led many FDA meetings and teleconferences.IND filings.NDA/CTD filing and approvals. -
Director Regulatory Affairs - Urology & OncologyGsk 2000 - 2003Research Triangle Park, NcResponsible for a drug in development for Benign Prostate Hyperplasia (BPH) and Prostate Cancer Reduction.Developed registration strategy and worked with FDA to get concurrence.Conducted pre-NDA meetings for the original NDA and sNDA.Submitted NDA and secured FDA approval.Managed launch advertising and promotional material.
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Associate Director Regulatory Affairs - Biologics & OncologyGlaxo Welcome Inc 1998 - 2000Research Triangle Park, Nc
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Assistant Director Regulatory Affairs - Biologics & OncologyGlaxo Welcome Inc 1996 - 1998Research Triangle Park, Nc
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Manager Regulatory Affairs - Oncology & RespiratoryGlaxo Welcome Inc 1995 - 1996Research Triangle Park, Nc
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Senior Regulatory Affairs Associate - OncologyGlaxo Inc Oct 1993 - Jan 1995Research Triangle Park
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Senior Staff FellowNational Institute Of Environmental Health Sciences (Niehs) Apr 1990 - Mar 1992Research Triangle Park, Nc -
Research AssociateUniversity Of North Carolina At Chapel Hill 1984 - 1990Chapel Hill, Nc
Munir Abdullah Skills
Munir Abdullah Education Details
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Biochemistry -
Biochemistry
Frequently Asked Questions about Munir Abdullah
What company does Munir Abdullah work for?
Munir Abdullah works for Mariam Clinic
What is Munir Abdullah's role at the current company?
Munir Abdullah's current role is Experienced Regulatory Affairs Executive.Chairman, Mariam Clinic Board..
What is Munir Abdullah's email address?
Munir Abdullah's email address is mu****@****ail.com
What schools did Munir Abdullah attend?
Munir Abdullah attended Queen's University Belfast, Karachi University.
What skills is Munir Abdullah known for?
Munir Abdullah has skills like Public Speaking, Project Management, Research, Strategic Planning, Cross Functional Team Leadership, Clinical Trials, Biotechnology, Regulatory Affairs, Pharmaceutical Industry, Fda, Drug Development, Microsoft Excel.
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Munir Abdullah
Sales Director - Middle East Hydrex Chemicals At Veolia Water TechnologiesSaudi Arabia1veoliawater.com -
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