Sanjay Thorat Email and Phone Number
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Sanjay Thorat personal email
I have initiated my pharmaceutical career in March-2005 as officer in Analytical Method development and Method Validation for Indoco Remedies Ltd.. After that I joined Ajanta Pharma Ltd in May-2007 as Research associate-Analytical Method development and Method Validation. I Left Ajanta in Aug-2008 to enter regulatory Affairs. So in all I have 3 and half years experience in Analytical Method development and Method ValidationI worked in Regulatory Affairs(ROW and Regulatory Market) for Elder Pharma ltd., J.B.Chemicals and Pharmaceuticals Limited and currently working in Pharmalink Consulting.
Abbott Healthcare Pvt Ltd - India
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- abbott.com
- Employees:
- 82486
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Regulatory Affairs ManagerAbbott Healthcare Pvt Ltd - India May 2020 - PresentMumbai, Maharashtra, IndiaManaging multiple activities according to agreed timelines and deliverablesActing as the CMC subject matter expert in cross-functional project teamsUtilising technical and regulatory knowledge and acumen to drive projectsEvaluating, interpreting, simplifying and communicating complex situations and dataEvaluating and interpreting legislation and regulatory intelligence and its business impactGenerating innovative and robust CMC regulatory strategiesIdentifying and evaluating regulatory risks and providing mitigation plans Identifying and executing process improvement initiativesProviding mentoring and coaching support and guidance to more junior colleaguesWriting and compiling high-quality right-first-time submission-ready CMC documentationLiaising with colleagues across multiple time zones and cultures
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Team Lead-Regulatory AffairsApotex India (Arpl & Apipl) Sep 2017 - May 2020Mumbai Area, IndiaManaging post-approval submissions for US, Canada and RoW market.Review and approve change controls via trackwise system for US, Canada and RoW market.Prepare and review L3 notifications, SNDS and SANDS for Canada.Prepare and review supplements for US (CBE-0, CBE-30 and Annual report).Prepare and review amendments for RoW market.Submission of eCTD supplements using DocuBridge software and via ESG getway to authorities.Preparation of monthly metrics for measuring team performance.Managing a teamMaintenance of various databases
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Assistant Manager-Regulatory AffairsGlenmark Pharmaceuticals Ltd. May 2017 - Sep 2017Mumbai Area, IndiaReview and approve change controlsPrepare and submit variation, supplements and annual reports for US.Co-ordinate with different stakeholders such as R&D, site, medical and purchase departments for gathering the data required for submissions.Preparation of approval packages after initial MA approval and subsequently after variation approvalMaintenance of various databasesEvaluation of reduced testing proposals for excipients/APIs/In-process specifications
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Manager-Pfizer ProjectGenpact-Pharmalink Consulting Mar 2012 - May 2017Mumbai Area, India Plan, prepare and review regulatory submissions for a wide range of products globally. Providing training to team members with regards to Regulatory updates, client systems and communication with client. Review and submission of CMC documents. Managing post-approval submissions. Query response Maintaining project database and tracking of projects to meet the submissions timelines. Authoring of CMC part of NDA, ANDA and IND Annual report. Co-ordination with client to achieve desired goals of projects. Dealing with Client’s Software for Dossier Management.
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Regultory Affairs ExecutiveJ.B.Chemicals And Pharmaceuticals Limited Dec 2009 - Jan 2012MumbaiAPI : DMF Submission to EU by eCTD (Software-Educe Solutions).Formulation : Preparation of Registration & Re-registration dossier for following countries as per Continent wise.USA : ANDA submission, CBE-0, CBE-30, PAS, labeling revision and Annual report by eCTD (Software-Educe Solutions).CIS : Russia, Turkmenistan, Tajikistan, Ukraine, Kazakhstan, Uzbekistan, Belarus, MoldovaAsia : Vietnam, MyanmarGulf : OmanAfrica : NigeriaCo-ordination with group members and other departments concerned with registration requirement and procedure.Documentation.
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Officer-Regulatory AffairsElder Health Care Ltd. Sep 2008 - Dec 2009Formulation : Preparation of Registration & Re-registration dossier for following countries Latin America : Haiti Asia : Sri Lanka, Vietnam, MaldivesCIS : Azerbaijan, TurkmenistanAfrica : Mauritus, Zambia, AlgeriaCo-ordination with group members and other departments concerned with registration requirement and procedure.Documentation.Coordinating with Packaging department for developing packing material as per country requirement.Maintaining status of registered and product to be registered for given country.Continuously updating the knowledge of registration requirement and guidelines. -
Research Associate -Analytical Method Development (Anda)Ajanta Pharma Ltd May 2007 - Aug 2008Routine analysis of Stability sample using HPLC, dissolution and UV Spectrometer.Development and Validation of Dissolution, Assay & Related Substances Methods.Calibration of HPLC, UV, pH meter and Dissolution apparatus.Fulfill regulatory requirement. -
Jr. Officer-Analytical Method DevelopmentIndoco Remedies Ltd Mar 2005 - May 2007Routine analysis of Stability sample using HPLC, dissolution and UV Spectrometer.Development and Validation of Assay Methods.Calibration of HPLC, UV, pH meter and Dissolution apparatus.Sample flow management.Fulfill regulatory requirement.
Sanjay Thorat Skills
Sanjay Thorat Education Details
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Institute Of Pharmaceutical Management.A -
52 %
Frequently Asked Questions about Sanjay Thorat
What company does Sanjay Thorat work for?
Sanjay Thorat works for Abbott Healthcare Pvt Ltd - India
What is Sanjay Thorat's role at the current company?
Sanjay Thorat's current role is Regulatory Affairs Manager at Abbott Healthcare Pvt Ltd - India.
What is Sanjay Thorat's email address?
Sanjay Thorat's email address is st****@****ing.com
What schools did Sanjay Thorat attend?
Sanjay Thorat attended Institute Of Pharmaceutical Management., Mumbai University.
What are some of Sanjay Thorat's interests?
Sanjay Thorat has interest in Swimming, Trekking, Cycling.
What skills is Sanjay Thorat known for?
Sanjay Thorat has skills like Regulatory Affairs, Pharmaceutical Industry, Regulatory Submissions, Ectd, Regulatory Requirements, Fda, Anda, Validation, Hplc, Ctd, Cmc, Regulatory Filings.
Who are Sanjay Thorat's colleagues?
Sanjay Thorat's colleagues are Margarida Maria Nascimento Costa, Juan Carlos Vera Henriquez, Christopher Lang, Nour Magdy, Alper Undefined, Nae Askani, Karen Taylor.
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Sanjay Thorat
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SANJAY THORAT
Senior Manager Manufacturing Engineering- Powertrain Division At Fiat India Automobiles Private Ltd Ii Manufacturing I Digitalization I Wcm Specialist & Auditor I Six Sigma Green Belt I Train The Trainer CertifiedPune
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