
With five years of global regulatory affairs experience in the pharmaceutical industry, I bring exceptional scientific and technical skills to support project management, regulatory affairs, quality assurance, and compliance. My vast knowledge of FDA guidelines and experience with electronic submissions such as eCTD and ESG, as well as IND and NDA regulations, CTA and MAA submissions to EMA, and health, enable me to navigate complex regulatory processes. Additionally, I have extensive expertise in rebranding and labeling procedures. I am experienced in updating SOPs, validation documents, post-approval changes, and qualification reports. My excellent written and verbal communication skills allow me to effectively communicate with individuals at all levels. As an independent professional, I excel both as a team member and a fast learner who easily adapts to new challenges and environments. I thrive under pressure in fast-paced work environments while maintaining precision in my work.