Regulatory Manager / Senior Regulatory Manager (Clinical Trials)

Location: Remote, Hungary

Company

hirify.global is a CRO integrating clinical trial execution with scientific expertise, laboratory capabilities, and advanced data sciences, with a focus on oncology and rare disease.

What you will do

• Provide regulatory strategy and development guidance throughout the clinical development lifecycle.
• Compile, coordinate, and review submissions to Regulatory Authorities and Ethics Committees, including CTAs, INDs, amendments, annual reports, scientific advice procedures, orphan designations, paediatric planning, and marketing applications.
• Develop and review submission documents for compliance with applicable regulatory standards.
• Represent Global Regulatory Affairs in internal and external project team and business development meetings.
• Lead regional or global regulatory projects, coordinate Regulatory Affairs Specialists, and maintain project plans, trackers, and regulatory intelligence tools.
• Provide ICH GCP guidance and training while supporting quality initiatives, regulatory standards, and staff development.

Requirements

• Bachelor’s degree or equivalent experience, ideally in a scientific or healthcare discipline.
• At least 5 years of regulatory experience for the Manager level or 7 years for the Senior Manager level.
• Regulatory affairs experience in a CRO or pharmaceutical company, including leadership of clinical submissions.
• Knowledge of drug development, clinical trial methodology, regulatory milestones, and regulatory activities in at least one major region, including the EU or US.
• Knowledge of relevant pharmaceutical development regulations and guidance, with the ability to interpret clinical and pre-clinical results for regulatory strategy.
• Professional English communication skills are required, along with availability for domestic and international travel, including overnight stays.

Culture & Benefits

• Remote work from Hungary within a growing global team.
• Work across multidisciplinary clinical, scientific, laboratory, and data science functions.
• Opportunities to contribute ideas and impact organizational improvements.
• Work on programs supporting the development of cancer and rare disease therapies.