Senior Regulatory Affairs Specialist

İstanbul, Turkey
İlan Tarihi
22 / 06 / 2020
Şehir
İstanbul, Turkey
Kategori
Diğer > Uzman / Kıdemli Uzman
Pozisyon Tipi
Dönemsel
Nitelikler, İş Tanımı :

We are looking for a ‘Senior Regulatory Affairs Specialist’ for our international business partner, which operates in Pharmaceutical Industry.

Job Description

· Responsible for coordination of regulatory processes with Local representative and ensure timely correspondences with global team,

· Supports registration of new products/line extensions and variation applications,

· Responsible for assuring that approved labelling is implemented in production in accordance with local legislation,

· 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.

Qualifications

· University (Bachelor of Science in Pharmacy, Chemistry) degree,

· Minimum 5 years of experience in regulatory affairs,

· Excellent verbal and written communication skills in English is a must,

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