Regulatory Affairs Leader | Navigating Global Compliance for New and Existing ProductsFrom shaping regulatory strategies across diverse global markets to ensuring seamless compliance with evolving policies, my journey in Regulatory Affairs has been a blend of strategic foresight and meticulous execution. Over the past 8 years, I have had the opportunity to work with leading pharmaceutical companies, spearheading regulatory activities that bridge innovation with market access.In my current role at Freyr, I work on behalf of Takeda Pharmaceuticals, leading and developing regulatory strategies for new products, existing products, and pipeline molecules. I manage regulatory activities across critical markets, including the US FDA, EU, APAC, GCC, and LATAM. Whether overseeing global clinical trials, handling product registrations and renewals, or driving lifecycle management, my focus is on ensuring compliance while enabling business growth.This journey has been built on my ability to collaborate with regulatory agencies, anticipate global trends, and mitigate risks. By developing and implementing regulatory policy and advocacy strategies, I ensure that our products not only meet current requirements but are also future-proofed against emerging regulations.Previously, I specialized in the technical aspects of regulatory submissions, mastering eSubmissions processes, including dossier compilation, publishing, and quality control for health authorities like FDA and EMA. I’ve worked with industry-leading tools like DocuBridge and Veeva Vault to streamline these submissions, ensuring accuracy and compliance at every step.If you’re interested in discussing how I can contribute to advancing regulatory strategies or have opportunities for collaboration, feel free to reach out to me at gksr1990@gmail.com. I’m always open to new challenges and meaningful conversations in the realm of regulatory affairs.