Manager 1

As a Manager 1 at Sun Pharma Laboratories Ltd in Guwahati - Regulatory Affairs, your role involves facilitating the harmonization and consistent implementation of Quality System and procedures at the site in alignment with Corporate Quality Policies/Procedures. Your responsibilities include: - Reviewing documents related to Quality Management System (QMS) & Compliance - Ensuring compliance of Quality Management System - Attending Site Training Program as per site training program and Global Quality Standards requirements - Submitting dossier documents after review against requests received from Corporate regulatory affairs - Responding to queries for submitted dossier against requests received from Corporate regulatory affairs - Handling export dispatch related queries for approved artwork of printed PM, Primary-packing material, overprinting, and other requirements - Conducting Export Harmonization activities between existing and new change implementation for Products - Reviewing and approving change control and deviation through QMS software, and obtaining prior approval from Regulatory if required for impact analysis - Initiating extension and variation proposals through QMS software - Handling Regulatory impact for Pharmacopoeia changes like IP, BP, USP implementation for export market products - Providing RA - Approval to Process Validation summary and signing other departmental documents where location regulatory approval is needed - Reviewing and approving product approval packages and sharing approval details with respective departments - Performing any additional activities allocated by the department head and site head Please note that these responsibilities are subject to change and additional duties may be assigned by the management as needed.,