Experience

Syncom Healthcare Ltd.

• India
• Pharmaceutical Manufacturing
• 100 - 200 Employee

• Executive regulatory affairs

  • Feb 2012 - Present

  • Review of plant generated Master documents (Art Works, Validation Protocol & Report, Stability Protocol, COA etc) with existing documents and approvals. • Review of new Specifications with the existing specifications. • To coordinate with AR&D, F&D, Q.C. & Q.A. to collect the complete set of documents. • Coordination with the different Plant teams for the compilation of plant related data such as Batch Production Records etc, required for filling purpose. • Managing SOP training records of personnel employed in RA department. • Review the documents at each stage of QC development. • Ensure the documents are error free and have minimum/no deficiencies. • Respond to the queries of Regulatory authorities and customers on time. • Review the process change proposals and provide guidance on change proposals. • Compile the dossier according to the particular Regulatory Authority. Show less



Akums Drugs & Pharmaceuticals Ltd.

• Haridwar Area, India

• Asst. officer DRA

  • Oct 2010 - Jan 2012

  • Preparation, Review and submission of Technical documents/Dossiers (CTD & ACTD format) related to Regulatory affairs for third country Export of Pharmaceuticals Formulations. • Checking and reviewing product artwork for country specific Regulatory compliance. • Compilation Stability Report for Semi-regulated & Regulated Markets. • Good hand in preparing Documents of stability Data, Protocol and Report. • Preparation, Review and submission of Technical documents/Dossiers (CTD & ACTD format) related to Regulatory affairs for third country Export of Pharmaceuticals Formulations. • Checking and reviewing product artwork for country specific Regulatory compliance. • Compilation Stability Report for Semi-regulated & Regulated Markets. • Good hand in preparing Documents of stability Data, Protocol and Report.