5.0 - 9.0 years

0 Lacs

guwahati, assam

On-site

As a Manager 1 at Sun Pharma Laboratories Ltd in Guwahati - Regulatory Affairs, your primary responsibilities will include: - Facilitating the 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 of the Quality Management System. - Participating in Site Training Programs as per site and Global Quality Standards requirements. - Submitting Dossier documents after review against requests received from Corporate regulatory affairs. - Responding to queries related to submitted dossiers as per requests 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 changes implemented for Products. - Reviewing and approving change control and deviations through QMS software, and obtaining prior approval from Regulatory if required, including impact analysis with detailed information. - Initiating extension and variation proposals through QMS software. - Handling Regulatory impacts for Pharmacopoeia changes such as IP, BP, USP implementation for export market products. - Providing RA approval for Process Validation summaries and other departmental documents where signature is required as location regulatory approval. - Reviewing, approving, and sharing product approval package details with respective departments. - Undertaking any additional activities allocated by the department head and site head. Your role will be crucial in ensuring the smooth operation and compliance of the Regulatory Affairs department at Sun Pharma Laboratories Ltd.,

Posted 1 day ago

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