Swetha Parikibanda

Regulatory Affairs @ADMA Biologics, Inc.

Boca Raton, FL, US

Participate in planning, preparing, and evaluating regulatory documents for submission to the FDA.Ensure compliance of corporate policies, procedures, and manufacturing/testing activities with regulatory requirements and approved INDs/BLAs.Stay updated on new laws and regulations and assess their impact on company products and processes. Work closely with Quality Assurance to conduct regulatory risk assessments of quality system documents and practices.Oversee Biological Product Deviation reporting and product recall procedures.Develop and maintain project timelines, submission tracking systems, and document archive systems.Review, write, and revise policies, SOPs, and work instructions to ensure efficient regulatory processes.Experienced in reviewing and approving promotional and advertising materials to ensure regulatory compliance, with direct submission and communication with regulatory agencies for approvals.

St. Cloud State University

Master of Science - MS, Regulatory Affairs & Services

Swami Ramanand Teerth Marathwada University

Doctor of Philosophy - PhD, Organic Chemistry