International Regulatory Affairs Specialist

Abdi Ibrahim Pharmaceuticals

Abdi İbrahim, founded in 1912, has the largest product portfolio in the sector and is the largest employer in the Turkish pharmaceutical industry with 4750 employees. Abdi İbrahim has been the leader of Turkey’s pharmaceutical industry since 2002 with its powerful vision. Today, Abdi İbrahim exports more than 60 countries. As a corporate citizen working towards creating a better world and a better future, adhering to its mission in the sector and to the requirements of societal priorities, Abdi İbrahim focuses on sustainability in all its business processes. Its vision for 2025 - apart from maintaining its status as a wholly local company - is to become "one of the top 100 pharmaceutical companies in the world.

· Bachelor’s degree in Pharmacy, Chemistry, Biology, Chemical Engineering or Molecular Biology,

· Minimum of 2 year of Regulatory Affairs experience in International Markets,

· Strong written and verbal communication skills in English,

· Second language (Russian, French) is preferable,

· Excellent communication, strong learning agility,

· Good knowledge on regulatory guidelines and procedures of regulated and other countries,

· Analytical, problem solving, presentation skills,

· Excellent follow-up, planning and organizational skills,

· Ability to manage a variety of cross-organizational projects, working closely with broad range of internal and external team,

· Proficiency in MS Office applications,

· No military obligation for male candidates.

· Submission of the marketing authorization application dossiers to the Ministry of Health of the relevant countries operating in the International Markets as per given timeline and portfolio,

· Preparation and submission of renewal dossiers,

· Follow up of variation applications,

· Coordinating all activities related to deficiency letters and preparing answers properly,

· Closely following national and international regulations and legislations

· Ensuring regulatory compliance with regional laws, regulations and guidelines

· Giving support to related departments on subject related to Regulatory knowledge and procedures,

· Archiving all correspondence and documents related to the products.