Rac Prabha Kannan

Highly Skilled professional with a broad range of experience in the pharmaceutical field and a history of exceeding performance in the areas of Regulatory Affairs Project Management, and Process Development. ---Key Values & Skills--- * Experienced in preparation of initial IND, NDA/BLA, CTA and MAA submissions to US, EMA, ASEAN, Mexico and other markets around the globe. * In Depth-Knowledge of the Strategic Planning & Implementation, Regulatory Compliance Initiatives, Authoring CTD sections, FDA Interactions and Project Documentation & Submission. * Familiar with industry standards Title 21 CFR Part 4, 11, 210, Part 211, Part 820 and ISO 13485 & 14971. * Excellent in verbal and communication skills with strong analytical and problem solving ability. * Proven ability to work efficient in both individual and team based environments and also a quick learner.