Managing Consultant, Health Science
Environment & Health
Mumbai
Namrata Gosar is an accomplished Regulatory Affairs professional with over 11 years of international experience in managing end-to-end regulatory processes for agrochemical products across diverse regions, including Canada, the US, Latin America, Europe, Africa, Asia Pacific, and the Middle East. She possesses deep knowledge of global regulatory guidelines and a proven track record of successful product registrations. She excels in leading cross-regional portfolios, developing regulatory strategies, and collaborating with government agencies, CROs, and internal stakeholders to ensure timely submissions and approvals.
Namrata’s expertise includes managing complex data packages, conducting field trials, overseeing dossier preparation for active ingredients and formulations, and evaluating technical data. Her proficiency spans the full regulatory lifecycle, encompassing new registrations, renewals, label expansions, task force initiatives, special review, and re-evaluation projects. Additionally, she is adept at budgeting, negotiating with CROs, and managing post-marketing compliance activities.
- Registration and Product Safety Stewardship
- Dossier preparation
- Regulatory Data Management System
- Technical data generation and coordination with CROs
- Collaboration with government agencies, internal and external stakeholders
- Regulatory lifecycle management
- Project Management
- Budgeting and negotiating with CROs