Nafees A.

 An accomplished Pharmaceutical professional with expertise in all stages of drug lifecycle management and experience in strategy implementation and submission management, eager to contribute to the success of a progressive organization.  Adept at recognizing, analyzing and proven success in achieving company goals and objectives in all aspects of day-to-day regulatory affairs and quality assurance initiatives to several therapeutic areas.  Set goals, establish priorities, manage resources, and develop strategies to stay abreast of regulatory requirements including FDA, GCC, ICH guidelines and relevant government regulations (21 CFR, EU Directive). Perform extensive research and analysis to timely and effectively prepare regulatory submissions, with additional emphasis in delivering electronic submissions focused on implementing the eCTD.  Evaluate industry trends and use findings toward designing and executing strategies to boost company leveraging. Excel at interacting with broad populations, including C-level executives, vendors, clients, and contractors.  Prepare, review and approve submission documents for CTD/ eCTD compliance.  Prepare final electronic PDF navigational competencies to all documents by applying blue-text, bookmarks, and hypertext linking to better accommodate Regulatory/FDA reviewers at time of submission.  Manage the quality control of all blue-texted, bookmarked, and hyperlinked documents prepared for electronic submissions.  Worked closely and directly with Medical writers, Regulatory submissions, Biostatisticians, Data Management and internal and external clients.