Kıdemli Ruhsatlandırma Uzmanı İş İlanı

University (Bachelor of Science in Pharmacy, Chemistry)

Minimum 5 years of experience in regulatory affairs

Strong planning and organizational skills, analytical thinking and result oriented, good cooperation and communication skills

The position has the responsibility to ensure local regulatory support for company assets including products registered by Legal Representative to ensure regulatory compliance of the products. This role also manages and supports submissions/approvals for Company products with the effective cooperation of all departments.

Responsible for coordination of regulatory processes with Local representative and ensure timely correspondences with global team for company products.

Supports registration of new products/line extensions and variation applications of company products.

Responsible for assuring that approved labelling (SPC, PL, pack) is implemented in production in accordance with local legislation.

Responsible for Regulatory translations for Turkey and coordination of translations in Turkey.

Supports local projects and department related assignments.

Responsible for archiving of regulatory files and documentation, and maintenance of regulatory databases.

Responsible for the review and approval of Advertising & Promotional materials in Turkey as per the approved SmPC, the Ethical Rules issued by local authorities and Company’s procedural documents.

Supports development and maintenance of the Turkey Regulatory QMS.

Promptly report knowledge (initial or follow-up) of any adverse event or quality product complaints associated with a company product within 24 hours or one business day of becoming aware of the event, in accordance with Company procedures.