Vinit Patel

Background

About Vinit Patel

I have a Bachelor of Pharmacy degree from ARIHANT SCHOOL OF PHARMACY, and I am currently pursuing a Master's degree in Regulatory Affairs at Northeastern University. I have gained valuable experience in Regulatory Affairs and Quality Assurance through my internship at Karyopharm Therapeutics, where I assisted with the review and update of the GCP quality documents, SOPs, and training records. I also participated in the preparation and execution of internal and external audits, and followed up on the corrective and preventive actions. I have a strong knowledge of the US FDA guidances, ICH guidelines, and 21 CFR regulations for drugs and medical devices, as well as the CTD/eCTD formats and the clinical trial databases. I am proficient in Project Management, Clinical Trial Management System (CTMS), and Microsoft Excel. My goal is to apply my skills and knowledge to the development and approval of safe and effective drugs and medical devices, and to contribute to the advancement of the healthcare industry. I am actively seeking full-time job opportunities in Regulatory Affairs and Quality Assurance, where I can leverage my education, experience, and competencies. I am a detail-oriented, dependable, and collaborative team player, who is eager to learn and grow in this field.