Regulatory Affairs Specialist – 18‑Month Fixed‑Term

About the role

We are seeking a Regulatory Affairs Specialist to support our global partner in the healthcare sector. The role is an 18‑month fixed‑term position focused on ensuring regulatory compliance for products marketed in Turkey.

Key responsibilities

• Coordinate timely communication with global teams regarding product registrations.
• Assist with submissions and filings for new products, line extensions, variations, and GMP documentation.
• Verify that approved labeling (SmPC, PL, packaging) is correctly applied in production according to local legislation.
• Support local projects and departmental assignments.
• Maintain regulatory archives and databases.
• Review and approve advertising and promotional materials in line with the approved SmPC, ethical rules, and company procedures.
• Contribute to the development and upkeep of the Turkey Regulatory Quality Management System (QMS).
• Collaborate with local and global teams to align regulatory strategies.
• Report adverse events or product quality complaints within 24 hours as required.

Required profile

• University degree in Pharmaceutical Sciences or a related discipline (Chemistry, Biology, Genetics preferred).
• Minimum 3 years of regulatory affairs experience in the pharmaceutical industry.
• Strong planning, analytical thinking, result‑orientation, and excellent communication skills.
• Willingness to travel as needed.

Required skills

• GMP knowledge
• Pharmacovigilance reporting
• Regulatory submissions and filing processes
• Regulatory database management