Regulatory Affairs Executive

About the role

The Regulatory Affairs Executive will join a dedicated regulatory team at a leading pharmaceutical and healthcare company in Istanbul. Reporting to the Regulatory Affairs Manager, the role involves managing regulatory activities throughout the product lifecycle and working on‑site at the company headquarters.

Key responsibilities

• Prepare and submit marketing authorization applications for pharmaceutical products in line with Turkish regulations.
• Coordinate lifecycle management tasks such as variations, renewals, post‑approval submissions and licence maintenance.
• Compile imported product registration dossiers using CTD/eCTD format.
• Handle regulatory correspondence, respond to deficiency letters and information requests from the Turkish Medicines and Medical Devices Agency (TİTCK).
• Ensure dossier completeness, accuracy and regulatory compliance.
• Collaborate with Quality, Medical Affairs, Pharmacovigilance, Supply Chain, Commercial and global manufacturing partners.
• Support GMP‑related activities and participate in inspections when required.
• Monitor regulatory developments and advise on compliance actions.

Required profile

• Bachelor’s degree in Pharmacy, Chemistry, Chemical Engineering, Biology, Molecular Biology, Biomedical Engineering or a related field.
• 5–8 years of regulatory affairs experience in the pharmaceutical industry.
• Strong knowledge of Turkish pharmaceutical regulations and licensing processes.
• Excellent written and spoken English.
• Proven communication, planning and stakeholder‑management abilities.
• Ability to work effectively in a cross‑functional, dynamic environment.

Required skills

• CTD/eCTD dossier preparation
• Regulatory submission management
• GMP compliance and inspection support
• Regulatory correspondence with TİTCK