Uluslararası Ruhsatlandırma Yöneticisi

Neutec

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 7 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,

·         Experience in team leadership/management

·         Excellent verbal and written communication skills in English,

·         Proficiency in MS Office,

·         Experienced in international regulations,

·         No restriction for travel,

Neutec is seeking for an “International Markets Regulatory Affairs Executive”.

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,

·         Manage the written correspondence with Ministry of Health before and after registration approval

·         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.