Chandan B

Regulatory Associate @Novo Nordisk

Bengaluru, IN

Managed the preparation, compilation, and submission of clinical trial applications (CTAs) in compliance with New Drugs and Clinical Trials Rules, 2019.• Coordinated the preparation and submission of Import License applications (CT-16) and major/minor amendments, ensuring accurate and timely documentation.• Led the creation and maintenance of regulatory dossiers in Veeva Vault, ensuring proper archiving, data request handling, and content planning.• Directed cross-functional teams in preparing and submitting clinical trial applications, collaborating with subject experts and internal departments.• Oversaw lifecycle management activities for marketed products, including post-approval changes, labeling updates, and regulatory submissions.• Managed the process for clinical trial notifications, annual progress reports, and safety reporting to health authorities.• Conducted quality checks on submission dossiers to ensure completeness, accuracy, and compliance with local health authority requirements.• Facilitated meetings with stakeholders, including regulatory bodies, internal teams, and project leads, to ensure alignment and compliance with regulatory standards.