Regulatory Affairs Executive

Role & responsibilities

The Regulatory Affairs Officer is responsible managing regulatory documentation and submissions in compliance with CTD dossier requirements, particularly for CIS and other regulated markets. The role involves review and preparation of technical and legal regulatory documents, coordination with internal departments and regulatory agencies, handling query responses, and ensuring accurate dossier compilation and tracking. The position also supports sample management, artwork review, laboratory data verification, and team coordination to ensure timely product registration and regulatory compliance.

Key Responsibility:

• Dossier Knowledge & Review:

  Knowledge of CTD dossier requirements, particularly for CIS countries, including dossier review, DMF verification, and technical data verification (QQ, SPECSTP, BMR, PVPPVR, PIF).

• Regulatory Documentation & Legal Compliance:

  Review and finalization of legal documents such as Product Permission, COPP, FSC, including notarization and apostillation, as per regulatory requirements.

• Regulatory Communication & Query Handling:

  Preparation and submission of regulatory query responses, TOC preparation as per guidelines for new countries or as required, and coordination with regulatory agencies.

• Artwork, Laboratory & Sample Review:

  Review of artwork for printing, analytical laboratory raw data related to samples, and responsibility for registration sample packing and related courier documentation.

• Tracking & Coordination:

  Maintenance of dossier submission trackers, query response data, courier tracking (samples and legal documents).