4 Pharmacopoeia Jobs

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.,

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. Evaluation of regulatory authority deficiencies and preparation of action plan accordingly. Also follow up of response documents with concern stake holders. Evaluation and approval of QMS documents, wherever applicable. To update cross functional teams for different regulatory compliance & requirements. Responsible for outlining requirements for labelling, storage and packaging. Review of product development report and QBD concepts. Updating product approval package to plant team. Preferred candidate profile Should Have Formulation Regulatory Affairs Relevant Experience in US/EU/Canada Perks and benefits

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. Evaluation of regulatory authority deficiencies and preparation of action plan accordingly. Also follow up of response documents with concern stake holders. Evaluation and approval of QMS documents, wherever applicable. To update cross functional teams for different regulatory compliance & requirements. Responsible for outlining requirements for labelling, storage and packaging. Review of product development report and QBD concepts. Updating product approval package to plant team. Preferred candidate profile Should Have Formulation Regulatory Affairs Relevant Experience in US/EU/Canada Perks and benefits

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 and method through change management process. Impact assessment of change. Review of ISO Guideline update. To coordinate with all interdepartmental activities pertaining to the USP/NF or other Pharmacopeial (if any) and ISO Guidelines. Report works completion status to reporting manager. Co-ordinate with Reporting manager for status update to the management. Preparation of quality metrics, Risk Assessment related to Compendial Review Team To perform the activity through QMS system compliance. Preparation, Review and implementation of Common SOPs / Procedures / Policies. Education & Experience: - M.Pharmacy/M.Sc Minimum 6 To 8 yrs experience as QC/QC reviewer/QA (GMP).