Regulatory and Start Up Specialist - Hungary
Remote · Budapest, Budapest, Hungary
Job Summary
Regulatory and Start Up Specialist responsible for country-level site activation activities, preparing and reviewing regulatory documents (ICFs, IP release, ethics submissions), ensuring SOP/WI adherence, maintaining internal tracking systems, and providing local regulatory expertise to project teams. The role supports SPOC duties across study teams, coordinates timelines and contingencies, and may involve communication with sponsors. Requires a Bachelor’s degree in life sciences or related field, 3 years of clinical research or equivalent experience, knowledge of GCP/ICH and regulatory guidelines, and fluency in Polish; it is a home-based opportunity based in Hungary (Budapest).
Required Qualifications
- Bachelor’s degree in life sciences or a related field
- 3 years’ clinical research or other relevant experience
- In-depth knowledge of clinical systems, procedures, and corporate standards
- Knowledge of GCP/ICH and applicable regulatory guidelines
- Understanding of regulated clinical trial environment and drug development process
- Ability to establish and maintain effective working relationships with coworkers, managers and clients
- Fluency in Polish language
- Home Based opportunity with local regulatory submissions and contracts
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