6 Pharmacopoeia Jobs

The Purpose of the Specialist role is to have expertise in Extractables and Leachables assessment and work closely with multiple functions such as MS&T, Supplier management, Regulatory, toxicology, Procurement, Quality, and Production. You will play a key role in supporting Extractable and Leachable activities with a strong focus on data collection, Risk rating, assessments, and evaluation. Key Responsibilities: - Understand Extractable and Leachable (E&L) risk assessment for materials based on supplier information and determine the risk level - Build a comprehensive material library backed by corresponding E&L test data - Manage the coordination for Extractables studies or product-specific ...

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 receiv...

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...

Role & responsibilities Handling of pre and post approval regulatory activities of US/EU/CA submissions. Review of developmental documents for regulatory submission. Good knowledge of handling CMC documentation for Dossier submission Compilation and Submission of Annual reports and Supplements. Having the experience of solid orals and injectables. Preparation of Sterility Assurance Package for injectable Dossiers. Preparation of Pre-IND/scientific advice meeting packages Drafting, compiling & eCTD publishing of dossiers for regulatory filings. Review of specifications and test procedure as per pharmacopoeia requirements. Providing regulatory support for customer filings and customer queries....

Role & responsibilities Handling of pre and post approval regulatory activities of US/EU/CA submissions. Review of developmental documents for regulatory submission. Good knowledge of handling CMC documentation for Dossier submission Compilation and Submission of Annual reports and Supplements. Having the experience of solid orals and injectables. Preparation of Sterility Assurance Package for injectable Dossiers. Preparation of Pre-IND/scientific advice meeting packages Drafting, compiling & eCTD publishing of dossiers for regulatory filings. Review of specifications and test procedure as per pharmacopoeia requirements. Providing regulatory support for customer filings and customer queries....

Job Posting Title Sr Compendial Review Associate Job Description Summary Job Description Summary • Performing identification of Pharmacopeial Updates and its review. Implementation of Pharmacopeial updates Globally through change management process. Performing activity related to revision of product specification and method. To support audit activity as per requirement. Incident & Change control review. CAPA implementation. Review and implementing the common procedures as per department requirement. Review of ISO Guideline update. Job Description: - Identification, review and Implementation of Pharmacopeial updates Globally. Performing activity related to revision of product specification an...