Zim Laboratories Ltd is hiring B. Pharma/ M. Pharma for Regulatory Affairs – Apply Now

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Zim Laboratories Ltd is seeking skilled B. Pharma and M. Pharma graduates for the role of Regulatory Affairs Executive in the vibrant Nagpur region. This is a fantastic opportunity to join a leading pharmaceutical company and contribute to ensuring compliance with regulatory standards. If you have a strong background in pharmaceutical sciences and a keen eye for detail, Zim Laboratories Ltd welcomes you to apply and become a part of their dedicated team. Explore your career potential with Zim Laboratories Ltd, a pioneer in innovative pharmaceutical solutions.

JOB RESPONSIBILITIES

• Preparation, review and planning of submission of CTD/ACTD/ECTD for export market.
• Floating of official email for technical documents and queries reply.
• Prepare/monitoring site registration documents for export market.
• Registration/Re-registration/post approval changes application for export market.
• Resolve the technical query related to product registration/Re-registration/post approval changes.
• Follow-up and coordination with internal stake holder ( QA, QC, R&D, Technical services
• Department, production, packing, account, purchase & business development).
  Review of technical documents, Process validation, Stability data, Analytical method validation, Product development report, finished product specification, Qualitative Quantitative formula, Standard testing procedure, batch manufacturing record, batch packing record, certificate of Analysis, container and closure system and open part Drug master file.
• To intimate & review of BE study from Approved BE center.
• Follow-up with manufacturing site for register sample, working standard & impurity requirement for lab analysis.
• To prepare monthly regulatory status report and status of new registration/Re-registration/post approval changes.
• Coordination with stakeholder for collecting documents for preparation of dossier, review of dossier and submission to respective regulatory authority.
• Review of artwork and pack insert as per rules laid by respective regulatory authority.
• Preparation and submission of Product safety update report.
• Coordinate the renewal of FDA license (GMP, COPP, manufacturing license, wholesale)

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