Kajal Patil

About Kajal Patil

Having leadership skills by actively participating in departmental improvement activities, such as system modifications, maintenance of standard operating procedures, internal guidelines. Also provided input to project regulatory strategies by assessing CMC changes, identifying global regulatory requirements. Have executed regulatory strategies by leading the development, authoring, and review of CMC submission components and documentation to support post-approval supplements, annual reports, registration renewals, and responses to health authority questions.Ability to assess and communicate potential regulatory risks, propose mitigation strategies, and lead the development and execution of global product and project regulatory strategies by ensuring a robust assessment of CMC changes, identification of global regulatory requirements, and critical evaluation of supporting documentation to confirm acceptability and identify potential risks. Understanding of regulatory affairs was applied to benefit the company to ensure approval and product supply continuity. Led the development, communication, lifecycle management, and review of the CMC Regulatory Strategy Document for projects of increasing complexity.Reviewed specifications, batch manufacturing records, batch packaging records, and provided query responses.Preparation of documents required for regulatory submission, such as master formula cards, stability study protocols, in-use stability study protocols for solid orals, sterile ophthalmic for regulated and semi-regulated markets, specific study protocols and reports like photo stability, tubing study, excipient compatibility study, filter study, and more. Also handled quality system documents like change control, deviation, corrective and preventive action, and prepared plant-related documents like technology transfer protocols/reports, handling of ERP system, raw material bill of material, documentation control, and archival.Overall, experience showcases expertise in the field of regulatory affairs, including ability to lead projects, assess potential regulatory risks, propose mitigation strategies, develop and execute regulatory strategies, and manage documentation for regulatory submission.

Experience

1. Lead Consultant

   Genpact

   Jan 2019 — Present · Maharashtra, IN

Education

• Vinayaka Mission's Research Foundation - University

  M.sc