Regulatory Affairs Professional

Accomplished Regulatory Analyst 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. Proven success in achieving and exceeding company goals and objectives in all aspects of day-to-day regulatory affairs and quality assurance initiatives. Adept at recognizing and analyzing several therapeutic areas of infectious disease, vaccines, anti-inflammatory, and tissue regeneration and engineering. Set goals, establish priorities, manage resources, and develop strategies to stay abreast of regulatory requirements including FDA, EMEA, 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, sales representatives, vendors, clients, contractors, and related stakeholders.

Clinical Regulatory Affairs

Doylestown, PA