Ramesh G. Email & Phone Number

Results oriented professional with full Regulatory Activities for Global CMC Authoring and Submissions for different Regions. Credited with progressive experience working with reputed Multinationals and other Global Market Leaders.Career profile includes experience in EU-MAA’s, Marketed Brands, Post Approval Changes and Global Regulatory Requirements. Persuaded end to end CMC knowledge in global organizations and exposed to work in multicultural environments.Expertise on:• CTD CMC Modules Writing• Life Cycle Management/Post-Approvals• Participate in Regulatory Submission Strategies & Submission Planning• Health Authority Questions Handling• Regulatory Portfolio Strategy