Niharika S. Email and Phone Number

As a Global Regulatory Affairs Lead, I work on CMC regulatory strategy and submissions for Oncology and Rare Disease (small molecules, biological and drug device combination) products. With over 13 years of experience in the pharmaceutical industry and a strong background in regulatory affairs, I lead regulatory strategy, submissions, and CMC documentation.I am proficient in managing the end-to-end planning, coordination, and execution of assigned deliverables, including delivering as an individual contributor. I have successfully handled initial registrations, query responses, renewals, and post-approval CMC activities for various markets, such as EU, US, Canada, and emerging regions. I have also demonstrated my publishing and tender skills, as well as my ability to author and review CTD modules. My goal is to ensure compliance, quality, and timeliness of CMC regulatory submissions, while supporting the development and launch of innovative and safe products.