Regulatory and Start Up Specialist
Remote · Hungary or HU
Job Summary
Regulatory and Start Up Specialist accountable for timely site activation readiness and regulatory submissions across assigned sites/countries, including preparing Clinical Trial Applications and submission dossiers for Competent Authorities and Ethics Committees, coordinating CA/EC interactions and responses, maintaining project plans and regulatory intelligence tools, supporting start-up plans and budget negotiations, and ensuring site activation milestones are met. The role involves translation coordination, document review and essential document collection, collaboration with site CRAs, and ongoing communication with Regulatory Leads, Project Management, and cross-functional teams. The ideal candidate possesses CRO/pharma/biotech regulatory/start-up experience, strong communication and organizational skills, English fluency, and may have an advanced degree or RAC certification.
Required Qualifications
- Bachelor’s degree in life sciences or related field (ideally in a scientific or healthcare discipline), or Registered Nurse (RN) or equivalent combination of education, training, and experience
- A qualification in Pharmacy/ work experience as a Pharmacist would be highly beneficial
- Demonstrated experience as a Regulatory or Start Up specialist (or comparable role) in either a CRO or pharmaceutical/ biotech industry or equivalent, relevant experience and/or demonstrated competencies
- Strong communication and organizational skills
- Experience using computerized information systems, electronic spreadsheets, word processing and electronic mail required
- Fluency in English
- Preferred: Advanced degree in medical or life sciences (MD, PhD, PharmD)/RAC certification/Masters in Regulatory Science
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