About the client: PSS has been mandated to hire a Regulatory Affairs Manager for one of the leading pharmaceutical companies in India.
  
Job Purpose: 
To register Formulation products in the European markets, handling all submissions and taking care of all queries.
  
Key Responsibilities: 
  • The candidate should have sound knowledge of all Regulatory Filings, be well-versed in e-CTD, Dossier submissions, be familiar with ICH guidelines, handled Educe dossier management and Lorange Doc bridge software for eCTD compilation and publishing.
  • Preparation of quality dossier (eCTD, CTD, ACTD, and Checklist) with regulatory compliance with respect to country requirements.  
  • Preparation of e-CTD dossier submission by using educe, track-wise.
  • Review of technical documents such as BMR, Process Validation Report, Analytical Method Validation Report, Stability Study Report, and all other documents pertaining to product registration.
  • Checking and developing text matter in Artworks (i.e. leaflets, carton & foil) as per requirement, such as specific storage conditions.
  • Review of Dossiers, Responsibility for Compilation of Dossiers.
  • Coordination in query response after regulatory submission. Synchronize with various departments (production, quality control, quality assurance, R & D, and F&D) to collect required input for timely regulatory submission of products.
Educational Qualifications And Experience: 
  • The candidate should have a B Pharm or M Pharm degree.
  • Age up to 38 years.
  • A minimum of 10 to 15 years of overall experience in Regulated Markets,
  • Especially European markets

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  Job Summary

Posted On:

03-Sep-2025

Function:

Medical Affairs

Industry:

Pharmaceuticals & Lifesciences

Location:

Delhi

Employment Type:

Full Time