Accomplished Senior Executive at Sun Pharmaceutical Industries Limited specializing in Regulatory Submissions & Dossier Management. Strong focus on fostering cross-functional collaboration. Successfully led creation and submission of 300+ regulatory dossiers, achieving a 90% approval rate and reducing approval timelines by 30%. Recognized expert in ensuring compliance with global standards, resulting in zero regulatory deficiencies and enhanced operational efficiency.
Overview
8
8
years of professional experience
Work History
Regulatory and Business Continuity
Sun Pharmaceutical Industries Limited
07.2016 - 07.2024
Adept in Regulatory Submissions & Dossier Management and fostering cross-functional collaboration
Spearheaded over 300 regulatory dossiers with 90% approval rate, significantly reducing approval timelines by 30%
Expert in ensuring compliance with global standards, leading to zero regulatory deficiencies and enhancing operational efficiency
Managed and submitted over 300 regulatory dossiers, achieving 90% approval rate and maintaining less than 15% query incidence on related submissions
Initiated and oversaw artwork review and preparation, ensuring compliance with regulatory guidelines for multiple markets
Successfully expedited product approvals for pharmaceuticals and health supplements across multiple emerging markets (APAC, LATAM, GCC, and Africa) by streamlining regulatory submissions and optimizing dossier preparation, resulting in 30% reduction in approval timelines
Achieved 100% regulatory compliance across all target markets by ensuring product registrations met local and international standards (EM, WHO, ICH), contributing to uninterrupted product availability in key regions
Managed lifecycle of over 300 regulatory dossiers for oral solid dosage forms drug formulations and food supplements, ensuring timely renewals, product variations, and adherence to post-marketing surveillance requirements, leading to zero regulatory deficiencies during inspections
Played key role in completing multiple regulatory audits with zero critical findings, enhancing company's reputation with regulatory authorities and ensuring ongoing market access
Collaborated with Quality Assurance to integrate regulatory requirements into 20 internal and external audits, continuously improving GMP compliance and product quality and ensuring smooth certification renewals
Developed and implemented proactive risk mitigation strategies that minimized impact of regulatory changes and supply chain disruptions, contributing to zero operational downtime across multiple regions
Maintained strong working relationships with key regulatory bodies e.g., CDSCO, enabling quick resolution of submission-related challenges and achieving timely approvals for variations and renewals of critical products
Supported regulatory submissions for 500 bioequivalence/bioavailability studies, ensuring all documents were prepared and submitted in compliance with ethics committees' requirements, resulting in seamless approvals and studies initiations
Accomplished Senior Executive at Sun Pharmaceutical Industries Limited, adept in Regulatory Submissions & Dossier Management and fostering cross-functional collaboration
Spearheaded over 300 regulatory dossiers with 90% approval rate, significantly reducing approval timelines by 30%
Expert in ensuring compliance with global standards, leading to zero regulatory deficiencies and enhancing operational efficiency
Education
Master of Science - International Health Economics & Pharmacoeconomics
Hochschule Fresenius
Wiesbaden, Germany
08.2026
Bachelor of Science - Pharmacy
Amity University
Noida, India
08.2016
Skills
Regulatory Information Management Systems (RIMS - Amplexor)
Manager -Regulatory Affairs and Business Continuit at Sun Pharmaceutical Industries LimitedManager -Regulatory Affairs and Business Continuit at Sun Pharmaceutical Industries Limited
<ul><li>Company Overview: Group Company of PUIG, Spain</li><li>Team Leadership & Process Excellence: Organised the transformation of the Finance & Accounts function, establishing performance-driven goals, and embedding a culture of accountability and continuous improvement. Drove operational efficiency through process redesigns, SOP implementation and optimal resource deployment, leading to measurable improvements in turnaround time and accuracy.</li><li>Strategic Partnering with CXOs: Acted as a key advisor to the CEO, CFO, and other CXOs on business planning, pricing strategies, and business model pivots to support scale-up and profitability. Contributed to investor communications with data-backed insights to enhance stakeholder confidence and secure strategic funding.</li><li>Cross-Functional & Global Stakeholder Management: Functioned as the strategic finance business partner to cross-functional heads and the PUIG global finance team, aligning local execution with global financial strategies and compliance requirements.</li><li>ERP Transformation & System Automation: Led end-to-end ERP reimplementation to address system gaps, enforce role-based controls, and automate core finance processes—resulting in enhanced data accuracy, faster reporting and improved internal controls.</li><li>Costing, Inventory & Profitability Optimization: Designed and implemented plant-level costing models to ensure accurate COGS determination. Improved inventory management across pricing, consumption tracking, and aging analysis—enabling better working capital control and cost efficiency.</li><li>Manufacturing Finance & Statutory Compliance: Supervised end-to-end accounting for manufacturing operations and ensured full statutory compliance.</li><li>Financial Reporting, MIS & Profitability Analytics: Delivered accurate and timely monthly MIS reports, including P&L, Balance Sheet and KPI dashboards with deep-dive variance analysis across stores, business verticals, and geographies. Supported board-level decision-making through insightful presentations on financial health and business performance.</li><li>Budgeting, Forecasting & Business Planning: Led the Annual Operating Plan (AOP) and rolling forecasts, ensuring alignment with strategic objectives and market dynamics. Monitored key financial metrics to enable business decisions and proactive cost management.</li><li>Statutory, Internal & Tax Audit Management: Finalized standalone and consolidated financials under Ind AS and IFRS, ensured timely group reporting and compliance with international standards. Delivered clean and timely closures of statutory, tax, and internal audits in coordination with Big 4 auditors. Strengthened audit readiness through pre-audit diagnostics and rectification of recurring control gaps.</li><li>Regulatory Compliance & Risk Management: Ensured end-to-end compliance which includes ROC, RBI, FEMA, Income Tax, GST, Transfer Pricing, DTAA, and Customs. Reviewed cross-border contracts and transactions to ensure arm’s length pricing, accurate TDS application, and proper documentation under Transfer Pricing regulations.</li><li>Commercial Negotiation & Contract Governance: Led commercial negotiations and structured deals with vendors and franchisees. Reviewed key business contracts to ensure financial viability, risk protection, and compliance with regulatory standards.</li><li>Treasury & External Commercial Borrowing (ECB): Managed fund planning and liquidity management including ECB drawdowns, bank negotiations, and interest optimization. Improved working capital cycles through proactive cash flow forecasting and receivables control.</li><li>Internal Controls & Governance Framework: Led organization-wide reviews of internal control systems, identified process gaps, and redesigned or implemented over 40 SOPs and IFCs. Established a governance structure for financial discipline, risk mitigation, and policy compliance across departments.</li></ul> at Kama Ayurveda Pvt. Ltd. & PUIG India Pvt. Ltd.<ul><li>Company Overview: Group Company of PUIG, Spain</li><li>Team Leadership & Process Excellence: Organised the transformation of the Finance & Accounts function, establishing performance-driven goals, and embedding a culture of accountability and continuous improvement. Drove operational efficiency through process redesigns, SOP implementation and optimal resource deployment, leading to measurable improvements in turnaround time and accuracy.</li><li>Strategic Partnering with CXOs: Acted as a key advisor to the CEO, CFO, and other CXOs on business planning, pricing strategies, and business model pivots to support scale-up and profitability. Contributed to investor communications with data-backed insights to enhance stakeholder confidence and secure strategic funding.</li><li>Cross-Functional & Global Stakeholder Management: Functioned as the strategic finance business partner to cross-functional heads and the PUIG global finance team, aligning local execution with global financial strategies and compliance requirements.</li><li>ERP Transformation & System Automation: Led end-to-end ERP reimplementation to address system gaps, enforce role-based controls, and automate core finance processes—resulting in enhanced data accuracy, faster reporting and improved internal controls.</li><li>Costing, Inventory & Profitability Optimization: Designed and implemented plant-level costing models to ensure accurate COGS determination. Improved inventory management across pricing, consumption tracking, and aging analysis—enabling better working capital control and cost efficiency.</li><li>Manufacturing Finance & Statutory Compliance: Supervised end-to-end accounting for manufacturing operations and ensured full statutory compliance.</li><li>Financial Reporting, MIS & Profitability Analytics: Delivered accurate and timely monthly MIS reports, including P&L, Balance Sheet and KPI dashboards with deep-dive variance analysis across stores, business verticals, and geographies. Supported board-level decision-making through insightful presentations on financial health and business performance.</li><li>Budgeting, Forecasting & Business Planning: Led the Annual Operating Plan (AOP) and rolling forecasts, ensuring alignment with strategic objectives and market dynamics. Monitored key financial metrics to enable business decisions and proactive cost management.</li><li>Statutory, Internal & Tax Audit Management: Finalized standalone and consolidated financials under Ind AS and IFRS, ensured timely group reporting and compliance with international standards. Delivered clean and timely closures of statutory, tax, and internal audits in coordination with Big 4 auditors. Strengthened audit readiness through pre-audit diagnostics and rectification of recurring control gaps.</li><li>Regulatory Compliance & Risk Management: Ensured end-to-end compliance which includes ROC, RBI, FEMA, Income Tax, GST, Transfer Pricing, DTAA, and Customs. Reviewed cross-border contracts and transactions to ensure arm’s length pricing, accurate TDS application, and proper documentation under Transfer Pricing regulations.</li><li>Commercial Negotiation & Contract Governance: Led commercial negotiations and structured deals with vendors and franchisees. Reviewed key business contracts to ensure financial viability, risk protection, and compliance with regulatory standards.</li><li>Treasury & External Commercial Borrowing (ECB): Managed fund planning and liquidity management including ECB drawdowns, bank negotiations, and interest optimization. Improved working capital cycles through proactive cash flow forecasting and receivables control.</li><li>Internal Controls & Governance Framework: Led organization-wide reviews of internal control systems, identified process gaps, and redesigned or implemented over 40 SOPs and IFCs. Established a governance structure for financial discipline, risk mitigation, and policy compliance across departments.</li></ul> at Kama Ayurveda Pvt. Ltd. & PUIG India Pvt. Ltd.