Strategic Regulatory Specialist offering nearly 13 years of career with diverse roles distinguished by commended performance and proven results across Regulatory Domain Proficient in designing, development and implementing project in Regulatory Publishing & Management, identifying improvement areas and implementing adequate measures to maximize customer satisfaction level Versatile, high-energy professional, successful in providing leadership to project teams and managing the day-to-day operations of domestic and international Regulatory projects Trusted leader, with comprehensive experience in creating global regulatory template/submission in eCTD/Paper/NeeS for various application such as IND, MAA, NDA, BLA, IPMD, CTA ANDA for submission to various regulatory Agency Hands-on experience in analyzing information system needs, evaluating end-user requirements, custom designing solutions and troubleshooting for complex information systems management Excellent track record of developing new regulatory policies, processes and SOPs and training key personnel on them; evaluating regulatory risks of division policies, processes, procedures Planned project activities such as time management, change management, delivery management & support as well as met deadlines and turnaround time without compromising quality norms and adhering to SLA Excellence in assessing and generating creative and innovative approaches in a variety of project settings to reduce process variations in line with various methodology principles Leading teams in the design, development, and delivery of consulting projects/components of larger, complex projects Supporting client engagement and defining pharmaceutical, and medical device regulatory service needs, project timeline, strategic goal, and expectation of delivery regulatory services Support regulatory services affairs services with an emphasis on regulatory strategy and the preparation, review, and submission of documents to regulatory authorities globally. Responsible for the implementation of regulatory systems for pharmaceutical, medical devices/life sciences companies. Project Management - managing project timelines and managing day-to-day communication with the client and team members.