India
Quality Assurance & Regulatory Affairs Leader with 18 years of experience in API pharmaceutical manufacturing in highly regulated global environments. Proven expertise in supplier lifecycle management, contract manufacturing oversight, supplier/contract manufacturing site domestic/overseas audits, global regulatory compliance, inspection readiness, quality systems strengthening and filing of regulatory dossiers in global markets. Successfully led and supported multiple regulatory inspections (USFDA, EDQM, PMDA, TGA, ANVISA, JFDA) with strong focus on sustainable compliance frameworks. Recognized for driving cross-functional alignment, improving audit outcomes, and establishing robust QA and documentation systems aligned with ICH, GMP, and global regulatory expectations. Led end-to-end qualification, auditing and performance monitoring of Intermediates/Starting materials/packaging material suppliers (domestic/overseas) including quality agreements. Responsible for qualification and compliance oversight of Contract Manufacturing Organizations (CMOs/CDMOs) including site audits & quality agreements. Established transporter qualification framework ensuring GDP compliance and audit readiness. Managed qualification and periodic audits of contract laboratories and ensured adherence to global GMP standards. Reviewed and approved Annual Product Quality Reviews (APQR). Conducted comprehensive data integrity audits across QA, QC, warehouse, and production systems. Coordinated site-wide self-inspection programs and internal audits, including audit reporting and CAPA closure. Directed document control, SOP lifecycle, and archival systems ensuring compliance with GDP and regulatory expectations. Oversaw raw material warehouse operations ensuring GMP compliance. Lead and managed a team of more than 20 QA professionals, including hiring, mentoring, and performance management. Investigated and resolved OOS (Out of Specification), OOT (Out of Trend), deviations and market complaints. Managed Process Validation, Equipment Qualification (IQ/OQ/PQ), and Cleaning Validation activities as per regulatory guidelines. Handled Change Controls and managed amendments in line with GMP requirements. Coordinated and successfully faced customer audits and regulatory inspections (USFDA, EDQM, PMDA, TGA, ANVISA, JFDA etc). Reviewed & approved quality documentation including SOPs, protocols, reports, and validation documents.
Led end-to-end qualification, auditing and performance monitoring of Intermediates/Starting materials/packaging material suppliers (domestic/overseas) including quality agreements. Responsible for qualification and compliance oversight of Contract Manufacturing Organizations (CMOs/CDMOs) including site audits & quality agreements. Established transporter qualification framework ensuring GDP compliance and audit readiness. Managed qualification and periodic audits of contract laboratories and ensured adherence to global GMP standards. Reviewed and approved Annual Product Quality Reviews (APQR). Conducted comprehensive data integrity audits across QA, QC, warehouse, and production systems. Coordinated site-wide self-inspection programs and internal audits, including audit reporting and CAPA closure. Directed document control, SOP lifecycle, and archival systems ensuring compliance with GDP and regulatory expectations. Oversaw raw material warehouse operations ensuring GMP compliance. Lead and managed a team of more than 20 QA professionals, including hiring, mentoring, and performance management. Investigated and resolved OOS (Out of Specification), OOT (Out of Trend), deviations and market complaints. Managed Process Validation, Equipment Qualification (IQ/OQ/PQ), and Cleaning Validation activities as per regulatory guidelines. Handled Change Controls and managed amendments in line with GMP requirements. Coordinated and successfully faced customer audits and regulatory inspections (USFDA, EDQM, PMDA, TGA, ANVISA, JFDA etc). Reviewed & approved quality documentation including SOPs, protocols, reports, and validation documents.
Led preparation, compilation, review, and submission of Drug Master Files (DMFs) in CTD format to regulatory authorities including USFDA and other global agencies. Prepared and managed Certificate of Suitability (CEP) dossiers for submission to EDQM, including initial applications, renewals, and revisions. Authored and reviewed Module 3 (Quality) sections of CTD dossiers, ensuring completeness and regulatory compliance. Coordinated cross-functionally with R&D, Process Development, Analytical Development, QA, QC, and Manufacturing teams to gather, verify, and compile technical data for submissions. Prepared, reviewed, and submitted responses to regulatory agency queries and deficiency letters within stipulated timelines. Acted as a key interface for handling customer queries related to DMFs and CEPs, providing regulatory and technical clarifications. Performed scientific review and gap analysis of dossiers to ensure completeness, accuracy, and compliance with current regulatory expectations. Evaluated change controls from a regulatory impact perspective. Monitored and interpreted global regulatory updates and guidelines relevant to API submissions. Supported lifecycle management activities including updates, amendments, annual reports, and variation submissions for existing filings. Maintained document control systems and regulatory databases, ensuring accuracy and traceability of submissions. Conduct internal training programs on regulatory requirements and updates for cross-functional teams. Represent regulatory function in senior leadership meetings and strategic planning. Part of global variation filings strategy ensuring minimal disruption to product supply. Act as the primary regulatory contact for specific products or portfolios across multiple regions. Manage regulatory commitments tracking and ensure timely closure.