Kruti Patel

WORK HISTORY

EDUCATION

SKILLS

ABOUT KRUTI PATEL

Strategic Regulatory Affairs professional with a demonstrated history of working in multiple therapeutic areas (Oncology, women\'s health, neurology, cardiovascular, gastrointestinal, nephrology, diabetes and pain) and across product life cycles, from the product development stage to post-marketing stages. • Regulatory Affairs and Quality Operations Certified – thorough knowledge of regulatory fundamentals including pre-market and post-market regulatory requirements for major jurisdictions such as Health Canada, FDA, EMA, ASEAN etc. as well as ICH/GMP requirements. • Regulatory Filings expertise: Health Canada (NDS, SNDS, ANDS, CTA, Administrative DIN, Level CMC changes, Pre-NDS/SNDS meeting package), FDA (NDA, ANDA, IND, PAS, CBE supplements) and EU (Type IA, Type IB, Type II variations, ASMF). • Execution of regulatory CMC development, registration strategies and submission for marketing authorizations, product variations and renewals, clinical trial applications and post-approval lifecycle activities. • Critical assessment and gap analysis of clinical, nonclinical and CMC dossier data related to in-licensing and due diligence activities to ensure compliance and develop strategic approaches with Canadian, US and other global regulations. • Successfully organized, prepared and participated in Pre-Submission, Advisory Committee and Type-A meetings with Health Canada and FDA. • Canadian promotional and non-promotional advertising materials and pharmaceutical products artwork and labelling. • eCTD submissions publishing via ESG gateway. • Subject Matter Expertise, project management, strategy & executional leadership to manage regulatory and quality areas, including but not limited to: Batch Reviews/Releases, CAPAs, Deviation/Non-Conformances, Investigations, Risk Assessments, Escalations, Audits and Compliance, Quarantines, Change Controls, Customer Complaints, Query Response, Documentation & Training etc. • Organized, motivated and team oriented with strong attention to details and excellent communication as well as organizational skills. • Flexible team player that thrives in environments requiring the ability to effectively prioritizes and juggle multiple, concurrent projects.