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Summary

regulatory professional having diverse experience of managing and monitoring regulatory submissions and approvals in more than 22 countries.

Experiences

Current Experience

  • Manager Regulatory Affairs


    Since October 2014
    - responsible for global Product registration, renewal application & license Applications in all countries. - responsible for global product variation Applications in accordance with the requirement of drug regulatory authority for any product / system / process related change. - monitor the complete registration process of submission and approvals in all operating countries. - involve in agreement finalization with regulatory and trade mark consultants. - lead the project for feasibility of products for regulatory submission and Marketing authorization. - lead the project for launching & Commercialization of consumer, herbal & otc products. - responsible for submission of nce’s for ex-registration Applications to drap. - Responsible for Global Product Registration, Renewal Application & License Applications in All Countries. - Responsible for Global Product Variation Applications in accordance with the requirement of Drug Regulatory Authority for any Product / System / Process related change. - Monitor the Complete Registration Process of Submission and Approvals in all operating countries. - Involve in Agreement Finalization with Regulatory and Trade Mark Consultants. - Lead the Project for Feasibility of Products for Regulatory Submission and Marketing Authorization. - Lead the Project for Launching & Commercialization of Consumer, Herbal & OTC Products. - Responsible for Submission of NCE’s for EX-Registration Applications to DRAP.

Past Experience

  • Assistant Manager Regulatory Management

    January 2013 --- September 2014
    - responsible for final review of Product registration, renewal application & license Applications. - responsible for final review of product variation Applications according to the requirements of respective regulatory authority for any product / system / process related change. - monitor registration processes and ensures timely submission and approvals in african region (kenya, nigeria, uganda, sudan and mauritius), asian countries (pakistan, yemen and afghanistan), cis region (kazakhstan & tajikistan) and francophone countries (ivory coast & cameroon). - review and verify all initial and developed product Packaging artworks in accordance with country specific labeling requirements. - involve in finalization of products for international submission. - responsible for impact assessment of any variation received from various departments as per Regulatory Compliance. - review of change alerts for any change in regulatory system and ensures its implementation. - review and implement SOP’s within team.

  • Asst. Manager Drug Registration

    January 2012 --- December 2012
    - responsible for review of Product registration, renewal application & license Applications. - monitor registration processes and ensures timely submissions and approvals in african region (kenya, nigeria, uganda, sudan and mauritius), asian countries (yemen and afghanistan), cis region (kazakhstan & tajikistan) and francophone countries (ivory coast & cameroon). - review all initial and developed product Packaging artworks in accordance with country specific labeling requirements. - involve in finalization of products for international submission. - review monthly reports and monitor regulatory trend Analysis. - review of query Compliance documents for onward submission to Health authority.

  • Sr. Executive Regulatory Affairs

    January 2011 --- December 2011
    - responsible for review of collated technical documents for the compilation of Product registration dossiers according to the regulatory requirements of export countries as per actd/ich - ctd requirements. - monitor registration processes and ensures timely submissions and approvals in asean region (vietnam, myanmar and laos), african region (kenya, uganda, sudan and mauritius) and in francophone countries (ivory coast & cameroon). - review monthly reports and monitor regulatory trend Analysis. - review of query Compliance documents for onward submission to Health authority. - assist in review of SOP’s for regulatory processes.

  • Executive Regulatory Affairs

    January 2010 --- December 2010
    responsible for review of collated technical documents for the compilation of Product registration / renewal dossiers according to the regulatory requirements of exporting countries. - responsible for regulatory correspondences and submissions in african region (kenya, uganda, sudan). - review monthly reports and monitor regulatory trend Analysis. - preparation of query Compliance documents for onward submission to Health authority. - preparation of initial text of insert and composition of artworks for registration and Commercialization purpose.

  • Sr. Officer Regulatory Affairs

    February 2008 --- December 2009
    - responsible for review of collated technical documents for the preparation of Product registration/renewal dossiers according to the regulatory requirements of exporting countries. - preparation of monthly reports and regulatory trend Analysis. - assist in preparation of query Compliance documents for onward submission to Health authority. - preparation of SOP’s for regulatory processes. - preparation of monthly plan for dossier preparation and related activities.

  • Management Trainee Regulatory Affairs

    November 2007 --- January 2008

Knowledge

LinkedIn Assessment :
Regulatory affairsPharmaceuticalsMarket researchBrand DevelopmentComplianceProduct developmentRegulatory submissionsPharmaceutical ManufacturingConsumer BehaviourSupply Chain ManagementPharmaceutical IndustryCleaning ValidationMarket accessClinical trialsMarketing ManagementCAPASales EffectivenessMarket PlanningValidationSOPPharmaceuticsFDAoncologyStrategyPharmacovigilanceTechnology transferLeadershipDiabetesClinical researchClinical pharmacologymanagementMarket AnalysisFormulationCompetitive AnalysisGeneric ProgrammingRegulatory RequirementsGood Laboratory Practice (GLP)V&VPharmaceutical saleseCTDQuality SystemsHPLCProduct launchQuality AuditingGMPCTDChange ControlICH-GCPSOP

Education

  • Master of Business Administration (MBA) in Marketing from Iqra University in 2013
  • B.Pharm in Pharmacy from Karachi University in 2005
  • Matriculation in Science from Gulistan Shah Abdul Latif School in 1998

Area / Region

Karachi, Sindh, Pakistan

Others

Driving License
  • No

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