SENIOR INTERNATIONAL REGULATORY AFFAIRS EXECUTIVE

SENIOR INTERNATIONAL REGULATORY AFFAIRS EXECUTIVEPosition SummaryThis role is responsible for ensuring that the company’s regulatory activities in international markets (EU, UK, GCC/KSA, CIS, etc.) are executed completely, compliantly, and on time. End-to-end management of documentation processes, correspondence with global authorities, strategic regulatory planning, and coordination within a multi-stakeholder structure are the core responsibilities of the position.Due to the diversity of the product portfolio and target markets, the role offers strong career development opportunities in strategic decision-making, gaining mastery of international regulations, and continuous professional learning.QualificationsEducation: Bachelor’s / Master’s degree in Pharmacy, Chemistry, Biology, Molecular Biology, Chemical Engineering, or related fields.Experience: 3–6 years of managerial experience in international regulatory affairs within the pharmaceutical industry.Languages: Advanced English; German is an asset.Technical SkillsAdvanced command of CTD – eCTD structureKnowledge of international regulatory requirements (EU, UK, GCC, CIS, etc.)Experience in dossier preparation and assessmentKnowledge of pharmaceutical manufacturing technologiesProject management competenciesStrong scientific and technical writing skillsPersonal CompetenciesStrong team collaborationExcellent communication and negotiation skillsTime management, analytical thinking, and problem-solving abilityStress management and ability to take initiativeCoordination skills in multi-stakeholder environmentsHigh discipline in documentation managementLocation: Ataşehir RegionResponsibilitiesDeveloping regulatory strategies aligned with target marketsPreparing, updating, and tracking CTD (Modules 1–5) dossiers in line with country regulationsManaging all formal correspondence with EMA, MHRA, SFDA, and other authoritiesProviding scientific and timely responses to authority questions (deficiency, clock stop, validation queries)Managing regulatory timelines in alignment with launch plansExecuting variation, renewal, and lifecycle management processesPreparing and updating SmPC, PIL, artwork, and labeling documentsCoordinating with R&D, Manufacturing, Quality, Analytical, and Supply Chain teamsManaging processes with external stakeholders (consultants, distributors, regulatory agencies)Monitoring international regulatory changes and communicating updates to relevant teamsHUMAN KAPİTAL Human Resources and Consulting Services Industry & Trade Ltd. is a private employment agency operating with the permission certificate No. 228 dated 20.06.2025 issued by the Turkish Employment Agency (İŞKUR). In accordance with Law