Regulatory Affairs Manager (PSS07756)

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

Skills Required

Regulatory Compliance, regulatory filings