Senior Regulatory and Start Up Specialist
New
P
Precision for MedicineClinical research
Remote, HungaryFull-TimeSenior
Salary not disclosed
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Job Details
- Languages
- Fluent in Hungarian; Fluency in English.
Requirements
- Hold a bachelor’s degree in life sciences or a related field, ideally in a scientific or healthcare discipline; be a Registered Nurse (RN); or have an equivalent combination of education, training, and experience.
- Have demonstrated experience as a regulatory or start-up specialist, or in a comparable role, in a CRO, pharmaceutical, or biotech industry setting, or equivalent relevant experience and competencies.
- Be fluent in Hungarian.
- Be fluent in English.
- Have experience using computerized information systems, electronic spreadsheets, word processing, and electronic mail.
- Have strong communication and organizational skills.
- Be able to prioritize workload to meet deadlines.
- Relevant regulatory and site start-up experience, including feasibility, contract negotiations, and CA/EC/IRB submissions, is preferred.
- Experience using milestone tracking tools or systems is preferred.
- A pharmacy qualification or work experience as a pharmacist is highly beneficial.
- An advanced degree in medical or life sciences, RAC certification, or a master’s in Regulatory Science is preferred.
Responsibilities
- Prepare clinical trial application forms and submission dossiers for initial submissions, amendments, and notifications.
- Submit documentation to competent authorities, ethics committees, and other applicable local bodies, and handle their responses.
- Monitor submission status and provide updates to study leads and project teams.
- Develop and maintain project plans, trackers, regulatory intelligence tools, and site activation timelines.
- Review and coordinate collection of essential documents required for site activation and IMP release.
- Customize country- and site-specific patient information sheets and informed consent forms, and coordinate document translations.
- Coordinate country start-up status and deliverables with feasibility, clinical operations, project management, regulatory, and site contracts teams.
- Maintain site-level critical path data, regulatory knowledge, audit readiness, and study documents in the relevant TMF.
- Support study budget and investigator contract negotiations, feasibility outreach, and pre-study site visits when required.
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