Regulatory Affairs Specialist

About This Role

This specialist role is for a regulatory affairs professional to join the Regulatory Affairs Department at Bilim Pharmaceuticals. The successful candidate will manage regulatory processes for products in international markets and prepare dossiers in EU-CTD format.

Responsibilities

• Plan and manage the regulatory processes for our products in targeted international markets
• Prepare and submit regulatory dossiers in EU-CTD format by monitoring country-specific regulations and legislations
• Execute and monitor license renewals and variation applications
• Establish effective communication with relevant official authorities and business partners to ensure smooth progress of processes
• Coordinate with internal departments (R&D, Production, Quality Control, etc.) to ensure the preparation and updating of necessary documentation
• Manage product labeling and packaging processes according to market requirements
• Keep track of current developments and changes related to regulatory processes and provide internal company updates

Requirements

• Bachelor’s degree in Pharmacy, Chemistry, Chemical Engineering or related departments
• Preferably at least 2–3 years of experience in the pharmaceutical industry, especially in international market regulatory affairs
• Advanced proficiency in English, both written and spoken
• Experienced in preparing dossiers in EU-CTD format
• Proficiency in MS Office programs
• Strong analytical and problem-solving skills
• Strong communication and negotiation skills
• Team-oriented with high organizational and planning abilities

About the Company

Established in 1953 with 100% Turkish capital, Bilim Pharmaceuticals is a leader in the Turkish pharmaceutical industry. It operates state-of-the-art manufacturing facilities in Gebze and Çerkezköy, employs over 2,500 professionals, and has a portfolio of more than 200 licensed products. The company advances human health in Turkey and exports to over 70 countries worldwide.