Regulatory Affairs Executive

About the Company Our client, a well-established company operating in the pharmaceutical and healthcare sector, is seeking a Regulatory Affairs Executive to join its Regulatory Affairs team located on the European side of Istanbul. About the Role Reporting directly to the Regulatory Affairs Manager, the successful candidate will become part of a team consisting of Regulatory Affairs Specialists and Senior Specialists, contributing to the management of regulatory activities across the product lifecycle. This position requires a full-time, office-based working model at the company headquarters and is not designed as a remote or hybrid role. Responsibilities Prepare and manage marketing authorization applications for pharmaceutical products in accordance with local regulatory requirements. Coordinate lifecycle management activities including variations, renewals, post-approval submissions, and maintenance of existing licenses. Prepare and compile imported product registration dossiers in CTD/eCTD format. Manage regulatory correspondence and responses to deficiency letters and information requests from the Turkish Medicines and Medical Devices Agency (TİTCK). Ensure all dossier modules are complete, accurate, and compliant with applicable regulations. Collaborate closely with Quality, Medical Affairs, Pharmacovigilance, Supply Chain, Commercial, and global manufacturing partners. Support GMP-related regulatory activities and participate in GMP inspections when required. Follow regulatory developments and provide recommendations to ensure ongoing compliance. Qualifications Bachelor's degree in Pharmacy, Chemistry, Chemical Engineering, Biology, Molecular Biology, Biomedical Engineering, or a related field. Minimum 5-8 years of Regulatory Affairs experience within the pharmaceutical industry. Strong knowledge of Turkish pharmaceutical regulations and licensing processes. Excellent command of English, both written and spoken. Strong communication, planning, coordination, and stakeholder management skills. Ability to work effectively in a cross-functional and dynamic environment. Preferred Skills Experience with regulatory submissions for countries outside the European Union. Hands-on experience managing imported pharmaceutical products and working with international manufacturing sites. Experience with reimbursement and pricing dossiers is considered an asset. Previous exposure to GMP applications and inspections.