Mine Aküzüm

Manage overall workflow across assigned regulatory affairs team to ensure appropriate resource allocation and the highest quality and compliant regulatory activity, Build and maintain close communication with health authorities and relevant governmental departments, Preparation, coordination and compilation of administrative and quality parts of regulatory dossiers for local (TR) and regional (CIS & MENA) submissions of products

Act as single point of contact and advisor for world wide regulatory intelligence information on the site, Coordinate documentation of source documents and contribute global team for CMC preparation, Ensure the Regulatory Compliance of the products manufactured within the site, Lead internal audits based on site annual plan, Contribution to cross-site collaboration within NTO Solids for Global audits/ HA inspections.

Coordinate, evaluate, prepare and submit drug registration applications, Build and maintain close communication with health authority and relevant governmental departments.

Prepare new CMC dossiers, variation packages, renewal submissions for TR, CIS or EU countries