RENU BAIRAGI
Karben
Summary
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, Germany08.2026
Bachelor of Science - Pharmacy
Amity University
Noida, India08.2016
Skills
- Regulatory Information Management Systems (RIMS - Amplexor)
- Artwork Management System (Agile)
- MS Office (Word, Excel, PowerPoint)
- Product Registration, Post-Marketing Surveillance & Lifecycle Management
- Compliance with FDA, EMA, WHO
- ICH Guidelines
- Good Manufacturing Practices (GMP) & ISO Compliance
- Cross-Functional Collaboration (Quality Assurance, Clinical, Supply Chain)
- Business Administration, Innovation
- Written and Oral Communication
- Ability To Lead, Curiosity & Reliable
Languages
English
Advanced (C1)
Timeline
Regulatory and Business Continuity
Sun Pharmaceutical Industries Limited
07.2016 - 07.2024
Master of Science - International Health Economics & Pharmacoeconomics
Hochschule Fresenius
Bachelor of Science - Pharmacy
Amity University
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