Kshitija Sawant

Assisted in preparing and reviewing regulatory documents and dossiers for cosmetic product approvals and renewals. Exposure to import/export license renewal under cosmetic rules 2020 , Warehouse license renewal, GMP renewal, Artworks and Additional packsize intimation to FDA Supported the label and artwork review process to check ingredient lists, claims, and compliance with CDSCO and BIS requirements. Helped in collecting and organizing product information, technical data, and safety certificates for submissions. Assisted in maintaining regulatory databases and tracking systems to ensure timely updates and document accuracy. Conducted basic research on Indian and global cosmetic regulations to support product launches and compliance checks. Worked closely with R&D, Quality, and Marketing teams to support new product development and ensure regulatory compliance. Supported the regulatory team during audits and inspections, ensuring all documents were complete and ready for review. Helped prepare presentations, summaries, and reports on regulatory requirements and product status. Most recently registered Toothbrush and waterflosser as Class A NSNM medical device in india.

1)Developing and implementing quality management systems (QMS). 2)Analyzing defects, deviations, and process inefficiencies, recommending improvements. 3)I have Worked closely with cross-functional teams to enhance production and service quality. 4)Identifying potential risks and implement preventive measures. 5)Investigating customer complaints or non-conformities and implement corrective actions. 6)Conducting root cause analysis (RCA) to minimize future issues. 7)Training employees on quality standards, best practices, and SOPs. 8)Maintaining and updating quality manuals, procedures, and records. 9) Ensuring all stakeholders understand and comply with quality requirements. 10) Conducting internal audits to identify gaps and ensure adherence to quality protocols. Regulatory Affairs Experience SFDA – MDMA Documentation: Prepared and submitted Medical Device Marketing Authorization (MDMA) documentation to the Saudi Food and Drug Authority (SFDA), ensuring compliance with regional regulatory requirements for dental aligners and Class II medical devices. USFDA – 510(k) Premarket Notification: Gained strong understanding of the USFDA 510(k) submission process, including predicate device identification, technical documentation requirements, and regulatory pathways for market clearance of medical devices in the U.S. CDSCO – Free Sale Certificate (FSC): Managed the application process and documentation for obtaining Free Sale Certificates through the Central Drugs Standard Control Organization (CDSCO) to support international product distribution. FSSAI Licensing Legal Metrology Compliance: Ensured product labeling and packaging met Legal Metrology Act standards, including verification of mandatory declarations and coordination with authorized agencies for registration and approvals.

1) analytical research and development lab 2) peptide bonding lab 3) Regulatory affairs - DMF , CTDs 4) Analytical chemistry lab - GC -MS , LC-MS