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Munir Abdullah is listed as Experienced Regulatory Affairs Executive.Chairman, Mariam Clinic Board. at MARIAM CLINIC, based in Raleigh-Durham-Chapel Hill Area, United States. AeroLeads shows a work email signal at cempra.com and a matched LinkedIn profile for Munir Abdullah.
Munir Abdullah previously worked as Chairman Of The Board at Mariam Clinic and Board Member and Adviser at Healthcare, Pharmaceuticals, Biotechnology And Not-For-Profit. Munir Abdullah holds Ph.D., Biochemistry from Queen'S University Belfast.
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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.
Listed skills include Public Speaking, Project Management, Research, Strategic Planning, and 25 others.
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Raleigh, North Carolina, United States
As 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.
Raleigh-Durham, North Carolina Area
Chapel Hill, North Carolina
As 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.
Research Triangle Park, Nc
Responsible 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.
Research Triangle Park, Nc
Responsible 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.
Research Triangle Park, Nc
Research Triangle Park, Nc
Research Triangle Park, Nc
Research Triangle Park, Nc
Quick answers generated from the profile data available on this page.
Munir Abdullah works for MARIAM CLINIC.
Munir Abdullah is listed as Experienced Regulatory Affairs Executive.Chairman, Mariam Clinic Board. at MARIAM CLINIC.
AeroLeads has found 1 work email signal at @cempra.com for Munir Abdullah at MARIAM CLINIC.
Munir Abdullah is based in Raleigh-Durham-Chapel Hill Area, United States while working with MARIAM CLINIC.
Munir Abdullah has worked for Mariam Clinic, Healthcare, Pharmaceuticals, Biotechnology And Not-For-Profit, Cempra Inc., Gsk, and Glaxo Welcome Inc.
You can use AeroLeads to view verified contact signals for Munir Abdullah at MARIAM CLINIC, including work email, phone, and LinkedIn data when available.
Munir Abdullah holds Ph.D., Biochemistry from Queen'S University Belfast.
Munir Abdullah is listed with skills including Public Speaking, Project Management, Research, Strategic Planning, Cross Functional Team Leadership, Clinical Trials, Biotechnology, and Regulatory Affairs.
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