Experience

• 

  Jawa Pharmaceuticals (Pvt.) Ltd.

  • Regulatory Affairs Consultant

    • Apr 2024 - May 2024

• 

  Fresenius Kabi

  • Pakistan

  • Regulatory Affairs Manager

    • Jun 2021 - May 2024
    • Pakistan

    Review of Technical justifications.Implementation of 2D barcode system.Ensure the implementation of Drug Act Pakistan 1976.Ensure the implementation of Health and OTC Act Pakistan.Ensure the implementation of DRAP Act 2012.Ensure the implementation of Medical Devices Rules 2017.Regulatory Intelligence.Business DevelopmentLicensing.Registration of products (Pharmaceutical, Medical Device & HOTC) for the localpurpose.Monitoring of Stringent Regulatory Authorities (USFDA, PMDA Japan, MHRA UK,Health Canada and other 13 countries) recommended by DRAP Pakistan for theregistration of products.Review of clinical and non-clinical Summaries, Substance data, Product data,clinical Literatures.Review of Product Renewals.Pricing (CPI, Hardship, NDA).Communication with DRAP (Lahore & Islamabad).Complied with safety and hazardous material handling, storage regulatoryrequirements and internal procedures affecting business operations.Developed and executed plans to monitor standard process adherence.Conducted field visits.Documented meeting minutes and distributed to staff to facilitate follow-up andpermanent record.Managed quality assurance program including on-site evaluations, internalaudits, and customer surveys.Developed standard operating procedures and document workflows for currentand future process steps.Possessed expert knowledge of competitive and third party products andtranslated knowledge into business strategy.

• 

  Dyson Research Laboratories Pvt Ltd

  • Lahore District, Punjab, Pakistan

  • Assistant Manager Regulatory Affairs

    • Nov 2020 - Jun 2021
    • Lahore District, Punjab, Pakistan

    Review of Technical/Medical Writing (Justificationregarding products if required by the Health Ministry,Training Modules for Market teams regarding theproduct, Clinical Literatures of Products, interdepartmentalcommunication regarding stability data,analytical validation data, process validation data,pharmaceutical development etc.Implementation of 2D barcode systemEnsure the implementation of Drug Act Pakistan 1976Ensure the implementation of Health and OTC ActPakistanEnsure the implementation of DRAP Act 2012Regulatory IntelligenceLicensingRegistration of products for the local and exportpurpose (CTD/ACTD) Regulation of Drug Laws ofImporting country for export purposes Monitoring ofStringent Regulatory Authorities (USFDA, PMDA Japan,MHRA UK, Health Canada and other 13 countries)recommended by DRAP Pakistan for the registration ofproductsReview of clinical and non-clinical Summaries,Substance data, Product data, clinical Literatures.Review of Product RenewalsPricingCommunication with DRAP (Lahore & Islamabad)Contract manufacturingComplied with safety and hazardous material handling,storage regulatory requirements and internalprocedures affecting business operationsImproved quality processes for increased efficiencyand effectiveness Created and managed knowledgebase to offer team immediate informational access toproducts technical InformationInvestigated and resolved customer complaints tofoster satisfaction Developed and executed plans tomonitor standard process adherence Conducted fieldvisitsDocumented meeting minutes and distributed to staffto facilitate follow-up and permanent recordManaged quality assurance program including on-siteevaluations, internal audits, and customer surveysDeveloped standard operating procedures anddocument workflows for current and future processsteps

• 

  Highnoon Laboratories Ltd

  • Regulatory Affairs Officer

    • Aug 2014 - Nov 2020

    Ensure the implementation of Drug Act Pakistan 1976Ensure the implementation of Health and OTC Act PakistanEnsure the implementation of DRAP Act 2012Regulatory IntelligenceRegulatory Requirement FormatLicensingRegistration of products for the local and export purpose (CTD/ACTDformat)Regulation of Drug Laws of Importing country for export purposesMonitoring of Stringent Regulatory Authorities recommended by DRAPPakistan (USFDA, PMDA Japan, MHRA UK, Health Canada, other 13countries) for the registration of productsPreparation of CTA/ACTD dossiers for product registration (clinical andnon-clinical Summaries, Substance data, Product data)Product RenewalsPricingCommunication with DRAP (Lahore & Islamabad)Contract manufacturingTechnical/Medical Writing (Justification regarding products if required bytheHealth Ministry, Training Modules for Market teams regarding theproduct, Clinical Literatures of Products, inter-department communicationregarding stability data and other clinical and nonclinical aspects)Conducted training and change management processes to improveoperationsComplied with safety and hazardous material handling, storage regulatoryrequirements and internal procedures affecting business operationsImproved quality processes for increased efficiency and effectivenessCreated and managed knowledge base to offer staff and customersimmediate informational access to products, services, and organizationInvestigated and resolved customer complaints to foster satisfactionDeveloped and executed plans to monitor standard process adherenceConducted field visits and met corporate customers for businessdevelopmentDocumented meeting minutes and distributed to staff to facilitate follow-upand permanent recordManaged quality assurance program including on-site evaluations, internalaudits, and customer surveysDeveloped standard operating procedures and document workflows forcurrent and future process steps