Binny Pathak

• Lead preparation, review and submission of CTD/ACTD and country specifc dossiers for Latam, MENA, Africa AND CIS .
• Variation, Supplements, ammendments and renewals of dossier in coutries like Latam, MENA, Africa and CIS.
• Ensure Submission are accurate, complete, and complient with regional and flobal regulations.
• Manage submission timeline and agency commitments.
• Provide regulatory input during product development and commercialization.
• Monitor changes in global regulatory requirements and guidelines.
• Manage and Mentor my team.
• Ensure aligment between regulatory approvals and commercial material.
• Coordinate and lead agency meetings,scientific advice and response to regulatory questions.
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Check all dossiers related documetsmfrom Third party manufacturer to make the dossiers for Latam, Aftica snd Asian courites.

• Check final dossiers for submission in Agency.
• Guide the team member about the query recieved from Agency and timely query reply.
• Apply dossier related legal documets like COPP, Product permission.
• Allot routine work through team member and take daily report withn them.
• Make lifescycle management of product through variation, annual report, retension, and renewal registration submission.

• Compile dossier and its submission as per regulatory requirements for Brazil, Mexico and Colombia.
• Evaluate query raised by Agency /customerand send timely reply.
• Part of a team which was responsible for new product development and get the registration of product as INNOVATOR in Brazil.
• Review manufacturing documents like PDR, BMR, Stability etc.
• Make application for LFDA & COPP.
• Review CCF.

• Work for dossier prepration for Brazil, Mexico, Peru, Chile and other Latin American coutries.
• Give training to team member.
• Quality check for dossier.
• Provide regulatiry inpout to product lifecycle planning.
• Good knowlege of legal documents.
• Cordination with Marketing, Quality control, ADL and other team for dossier related activity.

• Preparation of dossiers for Latin American courties.
• Knowledge gaining in sample dispatch.
• Applu legal documents for dossier submission.
• Also handle queries for different couries as time to time.

• In quality control department worked with dissolution machine, I.R, D.T and PH meter.
• Handling Active ingredients and Finished formulations.