Professional Experience
Team Lead, Regulatory Services
Celegence Systems Pvt Ltd, Bangalore
Aug 2025 - Present
Leading CMC-focused regulatory projects as project manager and SME, managing complex IND submissions and optimizing legacy dossiers.
- Lead end-to-end CMC gap assessments for legacy generic drug product dossiers (CTD/eCTD)
- Define remediation strategies for data generation and Module 3 updates
- Support CMC strategy for IND applications with phase-appropriate compliance information
- Serve as functional champion for CAPTIS AI-powered regulatory writing platform
- Manage CMC writer team performance and professional development
Regulatory Intelligence & RIM Lead | Compliance Consultant
Genpact, Mumbai
Apr 2021 - Aug 2025
Delivered regulatory intelligence, CMC consulting, and RIM implementation for global pharmaceutical companies across multiple regions.
- Coordinated 25+ successful submissions (ANDA, IND, CTAs) across US, EU, Australia, Canada, Japan with zero deficiencies
- Led migration and validation of 500+ regulatory documents into Veeva Vault RIM, improving accessibility
- Conducted regulatory data analysis to identify compliance gaps and process improvement opportunities
- Trained RA teams on Veeva RIM and Documentum processes and best practices
- Managed Brexit-related dossier activities and EU-UK regulatory alignment post-separation
Assistant Manager - Regulatory Affairs
Venus Remedies Ltd, Panchkula
Dec 2019 - Apr 2021
Managed end-to-end regulatory affairs for product registrations and lifecycle management across European and international markets.
- Compiled CTD/eCTD/ACTD dossiers for new registrations and variations
- Coordinated cross-functional data gathering from QA, QC, Production, and Development
- Prepared responses to regulatory deficiency letters and health authority queries
- Managed regulatory certifications (COPP, FSC, GMP, GLP, MMC)
- Led submission process revamp achieving 15% faster approvals across four regions
Executive Regulatory Affairs
Kusum Healthcare, Delhi
Sept 2017 - May 2019
Supported regulatory operations and product registrations for Indian and international markets with focus on dossier preparation.
- Prepared CTD dossiers for registrations and re-registrations in semi-regulated and international markets
- Liaised with State FDA to obtain regulatory certifications
- Streamlined RA procedures using digital tools, reducing dossier processing time by 25%
Officer - Quality Control
Glenmark Pharmaceuticals, Indore
Sept 2016 - Sept 2017
Performed analytical and wet chemistry testing for finished product quality release and stability studies under ICH guidelines.
- Conducted HPLC assay, related substances, and dissolution analysis
- Performed stability batch testing under ICH guidelines
- Executed dissolution and physical testing for routine QC and validation
- Collaborated on OOS investigation and CAPA documentation