Senior Executive
• Handled dossier preparation, their Life cycle management of the product license (Post approval Variations and Renewal activities) and online dossier submission through Health Agency Gateways• Performed client based project management services to provide scientific and technical guidance for pre and post authorisation activities in form of Regulatory Strategy Report • Handled scientific, technical and administrative responses to deficiencies and recommended action based… Show more • Handled dossier preparation, their Life cycle management of the product license (Post approval Variations and Renewal activities) and online dossier submission through Health Agency Gateways• Performed client based project management services to provide scientific and technical guidance for pre and post authorisation activities in form of Regulatory Strategy Report • Handled scientific, technical and administrative responses to deficiencies and recommended action based expertise• Reviewed dossier content for its completeness and ensured that submission content is in accordance with appropriate quality and compliance standards• Reviewed supportive documents required for the submission preparation (Product Development Report, Batch Manufacturing Records, Process Validation Reports) Show less