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