Our client, a leading clinical research organization providing end-to-end clinical trial management services across Europe, is seeking an experienced Regulatory Affairs Manager to join their growing team in Hungary. The company partners with global pharmaceutical and biotechnology firms, supporting innovative drug development through high-quality, compliant, and patient-focused research. The Regulatory Affairs Manager will play a key role in ensuring regulatory excellence, overseeing submissions through the Clinical Trial Information System (CTIS), and coordinating activities across multiple European countries.
Duties and Responsibilities:
- Actively participate in the start-up phase of clinical trials, ensuring full regulatory compliance.
- Implement and continuously improve regulatory affairs procedures in line with European and local standards.
- Supervise local regulatory officers, including oversight of Regulatory Intelligence maintenance and Clinical Trial Regulation File updates.
- Manage regulatory submissions via the CTIS platform, including initial submissions and substantial/non-substantial modifications.
- Coordinate local regulatory teams in the preparation and collection of country-specific documentation.
- Oversee quality control of regulatory documentation, reports, and notifications.
- Ensure adherence to applicable regulatory guidelines and company quality standards.
Requirements:
- University or college degree in a medical, pharmaceutical, or clinical research-related discipline (or equivalent experience).
- 1–2 years of direct work experience in regulatory affairs within clinical research.
- Strong understanding of CTIS procedures and European regulatory frameworks.
- Excellent IT proficiency and attention to detail in documentation management.
- Fluency in English (written and spoken); additional European languages are an advantage.
Should you be interested in the details of this vacancy feel free to submit your CV for this role, our colleagues will contact you soon.
Our client, a leading clinical research organization providing end-to-end clinical trial management services across Europe, is seeking an experienced Regulatory Affairs Manager to join their growing team in Hungary. The company partners with global pharmaceutical and biotechnology firms, supporting innovative drug development through high-quality, compliant, and patient-focused research. The Regulatory Affairs Manager will play a key role in ensuring regulatory excellence, overseeing submissions through the Clinical Trial Information System (CTIS), and coordinating activities across multiple European countries.
Duties and Responsibilities:
- Actively participate in the start-up phase of clinical trials, ensuring full regulatory compliance.
- Implement and continuously improve regulatory affairs procedures in line with European and local standards.
- Supervise local regulatory officers, including oversight of Regulatory Intelligence maintenance and Clinical Trial Regulation File updates.
- Manage regulatory submissions via the CTIS platform, including initial submissions and substantial/non-substantial modifications.
- Coordinate local regulatory teams in the preparation and collection of country-specific documentation.
- Oversee quality control of regulatory documentation, reports, and notifications.
- Ensure adherence to applicable regulatory guidelines and company quality standards.
Requirements:
- University or college degree in a medical, pharmaceutical, or clinical research-related discipline (or equivalent experience).
- 1–2 years of direct work experience in regulatory affairs within clinical research.
- Strong understanding of CTIS procedures and European regulatory frameworks.
- Excellent IT proficiency and attention to detail in documentation management.
- Fluency in English (written and spoken); additional European languages are an advantage.
Should you be interested in the details of this vacancy feel free to submit your CV for this role, our colleagues will contact you soon.