Ajithkumar Gurunathan
Assistant manager - Corporate Affairs (Regulatory Affairs) at endo India Par Formulation Pvt Ltd Chennai.
- Role
- Assistant Manager - Corporate Affairs at Endo
- Location
- Chennai, TN, IN
- LinkedIn followers
- 500 followers
About Ajithkumar Gurunathan
Aspiring professional, working in Regulatory Affairs. Looking forward to work in a…
Experience
Assistant Manager - Corporate Affairs
Feb 2023 — Present · Chennai, IN
Responsible for getting necessary approvals from State FDA, CDSCO, Central Bureau of Narcotics, Narcotic Control Bureau.> Responsible for getting necessary approvals related to Drug Licenses, Narcotic Drug Licenses, Psychotropic Substance, Controlled substance.>Preparation & Submission for NOC to CDSCO for Unapproved/New Drugs, Preparation & Submission to State Drugs Control for approved drugs to getting test license approvals.>Preparation & submission of Additional endorsement application to State FDA office whenever required.>Preparation & Submission of Import, Export Authorization for Narcotic/Psychotropic/ Controlled Drugs to respective department.> To get Technical Staff Approval/Removal from State FDA office whenever required.Review & follow-up from concern government authority like CDSCO, State FDA & NCB etc, department for getting approvals.>Filling required monthly/quarterly returns wherever applicable as per license conditions.>Monitor the applications, documentations and compliance are aligned as per various Government Acts and other laws as applicable before submissionTracking of the license validity, expiry and planning for renewal activities.>Tracking of the Import and Export License quantity details.>Technical Staff Approval/Removal certificate, Public Testing Facility License, Market Standing Certificate, Whole Conviction Certificate & Under Process Certificate.> BE-NOC along with Import License in Form-11 & Fresh and Renewal of Clinical Study Centre License.> Fire License, Pollution License, Hazardous Waste Authorization License & Sanitary License.> Absolute Alcohol License, Methanol License & Solvent Storage License.
Education
Anna University , BIT Campus , Tiruchirappalli (AUBIT)
Bachelor of Technology, Pharmaceutical Technology
2014 — 2018
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