Açıklama:
GENEL NİTELİKLER VE İŞ TANIMI
To be assigned to our company, which is one of the leading companies in the pharmaceutical industry;
· Bachelor’s degree in Pharmacy, Chemical Engineering or Chemistry departments,
· Minimum 2 years of experience in similar roles,
· Following new developments, solution and result oriented, giving importance to teamwork,
· Having knowledge of the requirements of personal and career development and being open to continuous development,
· Excellent verbal and written communication skills in English,
· Proficiency in MS Office,
· Experienced in international regulations,
· No restriction for travel,
JOB DESCRIPTION
· Preparation and submission of license dossiers in line with the relevant market requirements,
· Following the licensing process, responding to the requests from the relevant authorities by ensuring the necessary coordination with internal and external stakeholders,
· Preparation of technical documents according to current variation guidelines in variation applications,
· Conducting technical research on licensing procedures,
· Preparation of SPC/PIL in accordance with the relevant regulations,
· Taking an active role in the preparation process of artwork to be delivered to the relevant authority,
· Having knowledge of international regulations and legislation related to licensing.