International Regulatory Affairs Manager
On behalf of our corporate client operating in the pharmaceutical industry with a strong growth vision in global markets, we are seeking an International Regulatory Affairs Manager.
International Regulatory Affairs Manager
On behalf of our corporate client operating in the pharmaceutical industry with a strong growth vision in global markets, we are seeking an International Regulatory Affairs Manager.
Qualifications
- Bachelor’s degree in Pharmacy, Chemistry, Chemical Engineering, Biology, or related disciplines (Master’s degree is preferred),
- Proven experience in international regulatory affairs and global submission processes within the pharmaceutical industry,
- Excellent command of written and spoken English,
- Comprehensive knowledge of global pharmaceutical regulations, CTD/eCTD dossier preparation, and international health authority guidelines,
- Proficiency in document management software and electronic regulatory systems,
- Strong track record in cross-border stakeholder, project, and process management,
- Analytical mindset with strong strategic planning and regulatory risk assessment capabilities,
- Valid driver’s license and flexibility for business travel.
Job Description
- Formulate global regulatory strategies for target international markets, prepare submission roadmaps, and manage end-to-end authorization processes,
- Monitor regulatory updates and guidelines across different national health authorities to ensure company-wide compliance,
- Oversee new marketing authorization applications, variations, renewals, transfers, and licensing procedures,
- Coordinate the compilation, technical review, and submission of international regulatory dossiers (CTD/eCTD),
- Lead regulatory interactions and Q&A procedures with foreign health authorities, international business partners, and external consultants,
- Manage departmental timelines, budget tracking, and risk analysis while delivering periodic performance reports to executive management,
- Collaborate effectively with cross-functional internal and external teams to ensure timely project deliverables.
HUMAN KAPİTAL Human Resources and Consultancy Services Industry and Trade Limited Company is a private employment agency operating under permit no. 228, dated 20 June 2025, issued by the Turkish Employment Agency (İŞKUR). Pursuant to Law No. 4904 on the Turkish Employment Agency, it is prohibited to charge any fees to job seekers.