Jayesh More

Senior Regulatory Affairs Associate @Nora Pharma

Varennes, QC, CA

Lead, initial regulatory submissions (ANDSs, DINs), responses to Health Canada queries (e.g. Clarification requests, NON, NOD) and post-approval changes (SANDSs/SNDSs, Level Develop regulatory filing strategies, perform due diligence and gap analysis of the regulatory project intended for expansion to Health market, to secure timely approvals and product launces.• Helps regulatory team overcome challenges in the completion of projects. Managing interdepartmental coordination with technical stakeholders, business partners, and regulatory agencies. Provides regulatory strategic guidance and advice to achieve business goals.• Coordinate with global cross functional teams and global regulatory affairs (GRA) teams drive regulatory activities and filings.• Establish communication with Health Canada to understand reviewers\' opinions and bargain commercial perspective to acquire timely approvals as per launch planning.• Contributes to the creation and implementation of global regulatory strategies to improve the efficiency and quality of processes achieving global commercial requirements.• Maintain project status and provide inputs on timeline management for initial ANDS/NDS, responses to clarification requests, post-approval changes, and DEL applications. • Actively contribute for implementation of current regulatory practices and improvement of departmental process for efficient handling of regulatory submissions.• Monitor the regulatory environment, interpret changes, analyze gaps, and conduct impact assessment, and participate/lead implementation of systems/processes.