Regulatory Affairs Specialist

Vem İlaç San. ve Tic. A.Ş.

Vem İlaç is a Turkish pharmaceutical company headquartered in Istanbul.

With more than 1,700 colleagues, we carry out all our manufacturing at our EU-approved, cGMP-certified facility in Çerkezköy, enabling access to our medicines in more than 50 countries.

Our second facility in Lüleburgaz, scheduled to begin operations soon, will be the largest pharmaceutical production site in Türkiye and the region. This investment significantly expands our capacity and strengthens our global competitiveness.

Guided by science, we remain committed to meeting both today’s health needs and tomorrow’s challenges, as we continue to work for a healthier future.

Regulatory Affairs Specialist - International Markets

About The Role

We are looking for a Regulatory Affairs Specialist to support our expanding international operations by managing end-to-end regulatory processes in accordance with global standards. This role will be responsible for the preparation, submission and lifecycle management of marketing authorization dossiers across assigned countries, ensuring full compliance with local and international regulations.

Job Description

• Preparation and submission of marketing authorization dossiers in CTD format, in line with international regulatory requirements.
  
  
• Monitoring and follow-up of marketing authorization and analysis processess.
  
  
• Preparation, submission and tracking of variation applications for relevant markets based on product updates.
  
  
• Updating SPCs, PILs, and coordinating artwork preparation for international packaging. 
  
  
• Submission and follow-up of renewal applications in assigned countries.
  
  
• Coordinating the issuance of official documents from TITCK required by foreign authorities.
  
  
• Monitoring national and international regulatory updates and ensuring systematic archiving of all regulatory documentation and correspondence.
  
  
• Supporting regulatory activities by maintaining direct communication with regional partners and conducting on-site visits when necessary. 
  
  
• Ensuring effective coordination with Production, R&D, Quality and other relevant departments throughout all regulatory processes.

Qualifications

• Bachelor's degree in Pharmacy, Biology, Molecular Biology & Genetics, Chemistry or Chemical Engineering. 
  
  
• Minimum 3 years of experience in regulatory or related functions within the pharmaceutical industry.
  
  
• Proven experience in preparing CTD-format  dossiers.
  
  
• Advanced level of English.
  
  
• Proficiency in MS Office applications. 
  
  
• Strong team player with excellent collaboration and communication skills.
  
  
• Highly organized, detail-oriented, and disciplined working approach with strong time-management abilities. 
  
  
• Willingness and ability to travel domestically and internationally.
  
  
• Based in Ankara