Manager 1

As a Manager at Sun Pharma Laboratories Ltd in Guwahati, in the Regulatory Affairs department, your role involves the following responsibilities: - Facilitating harmonization and consistent implementation of Quality System and procedures at the site in alignment with Corporate Quality Policies/Procedures. - Reviewing documents related to Quality Management System (QMS) & Compliance. - Ensuring compliance with the Quality Management System. - Attending Site Training Program as per site training program and Global Quality Standards requirements. - Submitting Dossier documents after reviewing them against requests received from Corporate regulatory affairs. - Responding to queries on submitted dossiers as per requests received from Corporate regulatory affairs. - Addressing export dispatch related queries related to approved artwork of printed PM, Primary-packing material, overprinting, and other requirements. - Conducting Export Harmonization activities between existing and new changes implemented for Products. - Reviewing and approving change control and deviations through QMS software, and obtaining prior approval activity from Regulatory if required for impact analysis with detailed information. - Initiating extension and variation proposals through QMS software. - Handling Regulatory impact for Pharmacopoeia changes like IP, BP, USP implementation for export market products. - Providing Location RA approval for Process Validation summary and other departmental documents where signatures are required as location regulatory approval like APR, etc. - Reviewing and approving product approval packages and sharing approval details with respective departments. - Undertaking any additional activities allocated by the department head and site head. Please note that the company, Sun Pharma Laboratories Ltd, is a renowned pharmaceutical company known for its commitment to quality and compliance in the industry. As a Manager at Sun Pharma Laboratories Ltd in Guwahati, in the Regulatory Affairs department, your role involves the following responsibilities: - Facilitating harmonization and consistent implementation of Quality System and procedures at the site in alignment with Corporate Quality Policies/Procedures. - Reviewing documents related to Quality Management System (QMS) & Compliance. - Ensuring compliance with the Quality Management System. - Attending Site Training Program as per site training program and Global Quality Standards requirements. - Submitting Dossier documents after reviewing them against requests received from Corporate regulatory affairs. - Responding to queries on submitted dossiers as per requests received from Corporate regulatory affairs. - Addressing export dispatch related queries related to approved artwork of printed PM, Primary-packing material, overprinting, and other requirements. - Conducting Export Harmonization activities between existing and new changes implemented for Products. - Reviewing and approving change control and deviations through QMS software, and obtaining prior approval activity from Regulatory if required for impact analysis with detailed information. - Initiating extension and variation proposals through QMS software. - Handling Regulatory impact for Pharmacopoeia changes like IP, BP, USP implementation for export market products. - Providing Location RA approval for Process Validation summary and other departmental documents where signatures are required as location regulatory approval like APR, etc. - Reviewing and approving product approval packages and sharing approval details with respective departments. - Undertaking any additional activities allocated by the department head and site head. Please note that the company, Sun Pharma Laboratories Ltd, is a renowned pharmaceutical company known for its commitment to quality and compliance in the industry.