Regulatory Affairs Specialist (Istanbul, Turkey)

About the role

We are looking for a Regulatory Affairs Specialist to support the launch and maintenance of pharmaceutical products in Turkey. Reporting to the Regulatory Lead, you will ensure timely submissions, compliance with local regulations, and coordination with internal and external partners.

Key responsibilities

• Prepare and submit labeling, CMC variations and GMP dossiers for existing products.
• Manage renewal files, license transfers and packaging artwork approvals in collaboration with the labeling coordinator.
• Update and implement local regulatory procedures, track regulatory actions and keep internal systems current.
• Monitor market intelligence, interact with the Ministry of Health and advise management on regulatory strategy.
• Coordinate closely with local partners and the regional organization to ensure full compliance.

Required profile

• Bachelor’s degree in Pharmacy, Chemistry or Chemical Engineering (Pharmacy preferred).
• At least 2 years of regulatory affairs experience in the pharmaceutical industry.
• Fluent English and based in Istanbul.
• Strong strategic thinking, collaboration and negotiation abilities.

Required skills

• Regulatory submissions (labeling, CMC, GMP).
• Renewal and license transfer processes.
• Packaging artwork control and approval.
• Regulatory procedure development and system updates.
• Regulatory intelligence gathering and stakeholder communication.