Regulatory Affairs Manager

Role Overview

• Lead local regulatory submission activities for new marketing authorization applications, lifecycle management activities, label changes, technical updates, packaging updates, and post-approval variations for assigned products
• Prepare, compile, and submit local dossiers in line with Turkish legislation and Health Authority requirements, ensuring high quality and timely delivery
• Manage daily interactions with Turkish Health Authorities, including TİTCK/MoH, to support approvals, respond to questions, and close regulatory follow-up activities
• Design and execute GMP strategies, prepare GMP files, support inspections, manage renewals, and ensure timely GMP approvals
• Coordinate regulatory timelines and provide strategic regulatory guidance to internal stakeholders, ensuring alignment with commercial priorities and business objectives
• Support labeling, artwork development, Turkish translations, packaging compliance, and product information updates in line with local requirements
• Monitor and communicate changes in Turkish pharmaceutical legislation, regulatory policies, and packaging guidelines, providing proactive regulatory intelligence to the business
• Build strong partnerships with local commercial teams, Medical, Market Access, distributors, global regulatory colleagues, and external stakeholders
• Maintain regulatory compliance across marketed products, ensuring all activities are performed according to local and corporate standards
• Help navigate a fast-paced and evolving environment where processes may not always be fully established, bringing a proactive and solution-oriented mindset

Requirements

• Health Related sciences background and education (B.A or B.S; advance degree such as Masters’ would be a plus)
• A minimum 5-7 years’ experience in Regulatory Affairs in Türkiye
• Broad knowledge of Türkiye’s pharmaceutical legislation
• Strong ability to understand, interpret and apply local regulations, guidelines, policy statements, and influencing/ advising the operations accordingly
• Proven hands-on experience managing GMP submissions, GMP certificates, inspections, and Health Authority interactions
• Good experience in interfacing with relevant regulatory authorities
• Effective and positive interactions with regulatory agencies, and external network
• Ability to assimilate new knowledge rapidly and deep understanding of cross-functional drug development process and high scientific/clinical knowledge across key therapeutic areas to enable position holder to discuss compound
• Good Analytical skills, accuracy and reliability
• Ability to communicate effectively both orally and in writing, with proven persuasive, assertive and negotiating skills both internally and externally across functions
• Strong organizational, project management, and problem-solving skills
• Excellent written and verbal communication skills in both Turkish and English

Benefits

• Competitive salary
• Flexible working hours
• Professional development opportunities