Regulatoy Affairs Executive

I currently hold a master’s degree in Pharmaceutics and have two years of experience worked on FDA and EMA eCTD Submissions. Well versed with ICH quality guidelines, eCTD, CTD, SPL formats. I am fully versed in all aspects of FDA and EMA regulations

• CMC
• CTD
• EcTD
• Good Manufacturing Practices
• ICH Guidelines
• Labeling
• Publishing
• Quality Overall Summary
• SPL
• Validation

I currently hold a master’s degree in Pharmaceutics and have two years of experience worked on FDA and EMA eCTD Submissions. Well versed with ICH quality guidelines, eCTD, CTD, SPL formats. I am fully versed in all aspects of FDA and EMA regulations and policies regarding all medical products and understand the guidance that is used for these regulations. I can collaborate and interact with many different disciplinary groups to develop and register marketing strategies for any project.
I am able to conduct research for regulatory need and can allocate the affairs along with submitting advertising proposals and any promotions the client requires. In order to do this, I always keep up with the latest trends and merge all new requirements for each department.

Masters of Pharmacy