SENIOR INTERNATIONAL REGULATORY AFFAIRS EXECUTIVE

Position Summary

This 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.

Qualifications

Education: 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 Skills

• Advanced command of CTD – eCTD structure
• Knowledge of international regulatory requirements (EU, UK, GCC, CIS, etc.)
• Experience in dossier preparation and assessment
• Knowledge of pharmaceutical manufacturing technologies
• Project management competencies
• Strong scientific and technical writing skills

Personal Competencies

• Strong team collaboration
• Excellent communication and negotiation skills
• Time management, analytical thinking, and problem-solving ability
• Stress management and ability to take initiative
• Coordination skills in multi-stakeholder environments
• High discipline in documentation management

Location: Ataşehir Region

Responsibilities

1. Developing regulatory strategies aligned with target markets
2. Preparing, updating, and tracking CTD (Modules 1–5) dossiers in line with country regulations
3. Managing all formal correspondence with EMA, MHRA, SFDA, and other authorities
4. Providing scientific and timely responses to authority questions (deficiency, clock stop, validation queries)
5. Managing regulatory timelines in alignment with launch plans
6. Executing variation, renewal, and lifecycle management processes
7. Preparing and updating SmPC, PIL, artwork, and labeling documents
8. Coordinating with R&D, Manufacturing, Quality, Analytical, and Supply Chain teams
9. Managing processes with external stakeholders (consultants, distributors, regulatory agencies)
10. Monitoring international regulatory changes and communicating updates to relevant teams

HUMAN 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 No. 4904, no benefits of any kind may be obtained from job seekers, and charging job seekers a fee is strictly prohibited.