Prashant Chettri

Background

About Prashant Chettri

Regulatory Affairs professional with over 10+ years of Canadian healthcare and consumer product goods industry experience with proficiency in OTC drugs, NHP, medical devices, cosmetics, and consumer products. Proficient at managing multiple projects in fast-paced environment with below mentioned areas of expertise. • Lifecycle management of Drugs, NHP, Medical Devices, Cosmetics and Consumer products • Evaluation, preparation and submission of regulatory documentation to Health Canada (DINA, ePLA, CNF) and liaison with experts to clarify questions leading to approvals for product launches in multiple categories • Provision of regulatory assessment on critical change controls regarding compliant issues relating to CMC, manufacturing, labelling and supplier changes. • Review and approval of product claims, labelling, advertising materials / website for regulatory compliance. • Management of Medical Device/ Drug Establishment License and Site License including amendments, annual renewals and GMP renewal. • Liaising with the Marketing team, Legal, Quality Assurance, Regional Regulatory team to successfully launch products for Canadian business • Assessment of product formulations and label claims based on available claim substantiation documents and Canadian regulatory requirements. • Participation and monitoring of impact of changing Health Canada Regulations and advising its impact to business • Present monthly project updates and emerging Health Canada regulatory issue to management and cross-functional teams • Provide regular training to new marketing and global team members on Canadian regulatory guidelines and policies. • Participation in regular internal audits from regulatory compliance standpoint. • Representation of RB at various industry group meetings and sub-committee – CHP, CCSPA, CAPRA, CAC