Regulatory Affairs Manager (PSS07756)

About the client: PSS

Regulatory Affairs Manager

Job Purpose

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