Regulatory and Start Up Specialist

This is a fully remote position, open to applicants in Hungary.

📋 Description

• Accountable for the timely and quality delivery of site activation readiness within designated countries/sites while anticipating and addressing any potential risks.

• Preparation of Clinical Trial Application Forms along with the creation of submission dossiers (initial and amendments/notifications) for submission to Competent Authorities, Ethics Committees, and other relevant local entities in accordance with local regulations and timelines.

• Engage with Competent Authorities and Ethics Committees for study-related purposes and manage responses to these bodies.

• Provide regular updates regarding CA and EC submissions to the Start Up Lead and/or Regulatory Lead associated with the study, as well as to the Project Manager/Project Team.

• Maintain project plans, project trackers, and regulatory intelligence tools related to assigned duties.

• Assist in the development of study-specific start-up plans, IMP release requirements, and criteria for essential document reviews.

• Collaborate with the assigned site Clinical Research Associate (CRA) to ensure effective communication and facilitate site review, as well as manage the collection of essential documents necessary for site activation/IMP release.

⛳️ Requirements

• A Bachelor’s degree in life sciences or a related field (preferably within a scientific or healthcare discipline), or a Registered Nurse (RN) qualification, or an equivalent combination of education, training, and experience.

• A qualification in Pharmacy or relevant work experience as a Pharmacist would be highly advantageous.

• Proven experience as a Regulatory or Start Up specialist (or a similar role) within a Contract Research Organization (CRO) or the pharmaceutical/biotech industry, or equivalent relevant experience and demonstrated competencies.

• Excellent communication and organizational abilities.

• Proficient in using computerized information systems, electronic spreadsheets, word processing software, and email communication.

• Proficiency in English is required.

🏝️ Benefits

• Health insurance

• Flexible working arrangements

• Professional development opportunities