Kirthi Kottapally

Results-driven Drug Regulatory Affairs professional with nearly 13+ years of extensive experience in regulatory affairs within the pharmaceutical industry. Proven expertise in preparing regulatory dossiers for global Health Authority submissions, authoring, reviewing, and editing regulatory documents and presentations. Adept at serving as the Regulatory Affairs (RA) CMC project representative, ensuring compliance with US, EU, and global CMC regulatory requirements throughout product development and post-commercial maintenance phases.

• Successfully prepared and submitted regulatory dossiers for various Health Authorities, maintaining compliance with relevant regulations and guidelines.
• Coordination, compilation and review of regulatory CMC documentation (Module 1, Module 2 and Module 3 including Amendments) and related documents for CMC submissions according to agreed timelines and taking regional regulatory requirements into account.
• Acted as the Regulatory Affairs CMC project representative, providing expert guidance on CMC regulatory matters to cross-functional teams.
• Skilled in managing and configuring Veeva Vault RIM for regulatory information management, including document submission, registration tracking and compliance workflows. Experienced in optimizing system functionality to support regulatory operations and ensure data integrity.
• Leads the preparation, submission, and management of regulatory filings (NDAs, INDs, CTAs, BLAs, etc.) to health authorities.
• Knowledge of US, EU, Health Canada, and ICH regulatory requirements.
• Participate in the development of the CMC regulatory strategy for small molecules and Biologics. These submissions include health authority briefing packages, IND/CTA, NDA and MAA regulatory filings.
• Proficient in handling annual reports, variations, GVP modules, and other routine regulatory filings, ensuring timely and accurate submissions.
• Implemented tracking, execution, monitoring, and reporting processes for CMC activities to improve efficiency and achieve key performance indicators (KPIs).
• Led Compliance and Quality Management System (QMS) operational activities, including QE, CAPA, GxP training, and participated in Regulatory CMC audits and inspections.
• Demonstrated an in-depth understanding of CTD modules, drug development processes, and regulations. Skilled in writing regulatory modules for CTD system and managing project scope and timelines effectively.
• Provided regulatory input on manufacturing changes through the evaluation of CMC change controls.
• Developed and compiled labeling documents in alignment with company goals and submission requirements, ensuring accuracy and compliance.
• Collaborated with cross-functional teams in Quality Assurance, Compliance, Global Manufacturing and Supply, Pharmaceutical Sciences, Global Regulatory Operations, and Local Operating Companies to drive compliance and continuous improvement initiatives.
• Devised and executed regulatory CMC strategies for addressing Health Authority information requests.
• Knowledge on Types of DMF, Regulatory bodies, stability conditions & Climatic zones and modules of CTD and ACTD.