Priya Patil

To integrate and apply the multidisciplinary regulatory sciences of Pharma Products, Medical Devices, Clinical Studies, FDA regulations, guidelines, and compliance to significantly contribute to the organization's mission and goal. I am efficient, rigorous, precise, detail-oriented, and passionate about this field. I am highly organized, able to prioritize and organize work to meet deadlines, and efficient in individual and team settings. I possess critical thinking, problem-solving, and fast learning skills, which I am eager to apply in the regulatory science field.

Summary of Education and Professional Experiences M.S. in Regulatory Sciences - Pharma Products, Medical Devices, and Clinical Studies, GPA: 4.0 Acquainted with Clinical Trial regulations and IRB requirements and submissions Through knowledge of CTD submission process and Quality Assurance, including 21 CFR 820, 21 CFR 11, 21 CFR 211, and CAPA. This knowledge, coupled with my implementation of quality assurance and process validation, batch records, and SOPs, positions me as a competent professional in the field. Implementation of quality assurance and implementations of process validation, batch records, and SOPs Through knowledge of Pharmaceuticals, Biologics, and Medical Devices, regulatory and approval pathways Through knowledge of Medical Device class-I, II, and III guidelines and approval process Experience in Deep Brain Stimulator Medical Device Effective oral communication and scientific writing skills Experienced in FDA regulatory guidelines and compliance with nasal spray pharma products at Adept- Biopharma Consulting, Litigation, and Patent Expert LLC as a Pharma Regulatory Assistant Maintaining of product labeling per FDA regulations/guidance Verify pharmaceutical labels to ensure compliance with FDA's regulatory guidelines Biopharma Research and Development (R & D) assistant experience in formulation and characterization of anti-lung cancer Extended-Release Docetaxel loaded Nano liposomal suspension products in a research laboratory at the College of Pharmacy. Knowledge of Medical Terminologies used in the clinic and pharmacy Completed a Diploma in Pharmacy and grasped the understanding of pharmaceutics, pharmacology, medicinal chemistry, anatomy, physiology, hospital, and clinical pharmacy

• Scholar plaque, Bachelor of Science, JSS College, Gokak, Karnataka University
• Scholar plaque, Diploma in Pharmacy, KLE Society's College of Pharmacy, Nipani, Karnataka