More than 20 years of experience in regulatory affairs for Rest of the World market.Specialties: Regulatory Affairs
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General ManagerBliss Gvs Pharma Ltd.Mumbai, Mh, In -
Deputy General ManagerBliss Gvs Pharma Ltd. Dec 2020 - PresentMumbai, Maharashtra, IndiaLeading Regulatory Team for ROW Market -
Assistant General ManagerMacleods Pharmaceuticals Ltd. Apr 2018 - Nov 2020 -
Sr. Manager - Regulatory AffairsMacleods Pharmaceuticals Ltd. Jul 2014 - Mar 2018MumbaiLeading ROW Team for Africa & South East Asian MarketCountries under profile are:Botswana, Ethiopia, Ghana, Kenya, Madagascar, Mozambique, Namibia, Nigeria, Sudan, Tanzania, Uganda, Zambia, Zimbabwe.Benin, Burkina Faso, Cameroon, DR Congo, Congo Brazzaville, Gabon, Guinea, Ivory Coast, Mali, Senegal, Togo.Cambodia, Sri Lanka, Malaysia, Myanmar, Philippines, Thailand, Vietnam. -
Manager - Drug Regulatory AffairsAlkem Laboratories Ltd. Oct 2011 - Jul 2014KhargharLeading ROW Team for CIS & African MarketCountries under profile are:Benin, Burkina Faso, Cameroon, Congo, Gabon, Ivory Coast, Senegal, Mali, Togo, Vietnam, Sri Lanka, Malaysia, Ethiopia, Ghana, Kenya, Nigeria, Tanzania, Uganda, Zimbabwe, Azerbaijan, Belarus, Georgia, Kazakhstan, Russia, Ukraine, Uzbekistan, Sudan, Iraq, Kuwait, Oman, UAE, Yemen. -
Assistant Manager - Regulatory AffairsUnichem Laboratories Limited Oct 2007 - Oct 2011Handled ROW Team. Countries under profile are CIS, Africa, ASEAN, South AfricaMonitoring performance of sub-ordinatesi) Work allocationii) Periodical monitoringiii) Performance assessmentCompilation of product & company registration dossiers for ROW (Rest of World) market.Co-ordination with Corporate Department such as IBD, ARD, PTD, Medical, Commercial, Packaging Development & Manufacturing Location such as QA, QC, Production, Stores etc.Review of Technical documents such as MPRs, Specifications, COAs, Process Validations, Method Validations, Stability etc.Preparation of query response & re-registration dossiers for various ROW countriesPreparation of Tender documents for various ROW countriesInteraction with agents, distributors, CBMs, Consultants etc. -
Executive - Regulatory AffairsZynova (Oman) Jun 2006 - Sep 2007Prepared dossiers for GCC countries & GCC DR.
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Officer - Regulatory AffairsOne World Pharma Ltd. Nov 2002 - May 2006Dossier PreparationPrepared CTD Format Dossiers for Morocco CountryPrepared EU Format Dossiers for Albania, Turkey, Morocco etc. countriesPrepared Special Format Dossiers for IDA NetherlandsTender done for countriesNorthern Cyprus, Palestine, Chad, Gabon, Cameroon, Guyana, Togo, Tanzania, Burkina Faso
Nitesh More Education Details
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Institute Of ScienceChemistry -
D. G. Ruparel CollegeChemistry -
Arwind Gandbhir High SchoolS.S.C
Frequently Asked Questions about Nitesh More
What company does Nitesh More work for?
Nitesh More works for Bliss Gvs Pharma Ltd.
What is Nitesh More's role at the current company?
Nitesh More's current role is General Manager.
What schools did Nitesh More attend?
Nitesh More attended Institute Of Science, D. G. Ruparel College, Arwind Gandbhir High School.
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Nitesh more
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