I graduated with a Master's degree in Biomedical Regulatory Affairs from University of Washington, where I learnt about the regulatory landscape and processes for drugs, devices, and biologics, as well as the scientific, legal, and ethical aspects of regulatory affairs. My academic background also includes a Master's degree in Environmental Protection and Agricultural Food Production from the University of Hohenheim in Germany, and a Bachelor's degree in Microbiology from the University of Mumbai in India.I interned at Seagen in Summer 2023 as Regulatory Affairs CMC Intern , a leading biotechnology company that develops and commercializes innovative cancer therapies. I support the CMC (Chemistry, Manufacturing, and Controls) team in preparing and reviewing regulatory submissions, ensuring compliance with global regulatory requirements and guidelines, and managing regulatory documentation and databases.With over three years of experience in Quality Assurance in Germany, I have developed strong skills in auditing, risk management, and quality control, as well as a keen eye for detail and accuracy. I have worked with cross-functional teams to implement and maintain quality management systems, such as ISO 9001 and ISO 13485, and to ensure adherence to quality standards and regulations for medical devices and software products. I have also contributed to continuous improvement initiatives and customer satisfaction projects, using data analysis and problem-solving techniques.I am passionate about the field of regulatory affairs and quality assurance, and I am always eager to learn new skills and best practices. I have completed multiple certifications in topics such as designing of educational games, metagenomics, and microfluidics, and I have also acquired skills in Veeva Vault, ELISA, and molecular biology. I am fluent in German, Hindi, and Marathi, and I have excellent communication and interpersonal skills. I thrive in fast-paced, challenging environments, and I am committed to making a positive impact in the field of regulatory affairs and quality assurance.
