Regulatory Associate_Temporary

TW Bilgi ve İletişim Hizm. A.Ş.

• Relevant scientific degree or Bachelor's degree in pharmacy or life sciences (pharmaceutical, medical, chemical) required.
• Min 1-2 years experience
• Good knowledge of written and spoken English.
• Foundational knowledge and understanding of local and global regulatory procedures as well as European ones as applicable.
• Able to make decisions that impact own priorities and allocation of time to meet deadlines.
• Strong knowledge of quality systems.

İŞ TANIMI

• Obtaining and maintaining product licenses for marketing affiliate by preparing and filing submissions to local regulatory agency, e.g. new products, line extensions, variations (Chemistry, Manufacturing and Control (CM&C), new indications, labeling etc.), renewals, co-marketing and GMP submissions for the inspections.
• Maintaining complete archive of all MoH communications and all submitted and proposed documents (product dossier, etc.)
• Responding to queries on regulatory processes and regulatory status.
• Using appropriate local and global SOPs as required by the Safety and Efficacy Quality System (SEQS).