Regulatory and Start Up Specialist

Job Description

Precision for Medicine is seeking a Regulatory and Start Up Specialist to join their team in Belgium. This role is fully home-based and focuses on ensuring the timely and high-quality delivery of site activation readiness. The specialist will foresee and mitigate any risks associated with the process.Responsibilities:

• Preparing Clinical Trial Application Forms and submission dossiers for regulatory bodies.
• Interacting with Competent Authorities (CA) and Ethics Committees (EC) for study purposes.
• Providing regular updates on submissions to the Start Up Lead, Regulatory Lead, Project Manager, and Project Team.
• Maintaining project plans, trackers, and regulatory intelligence tools.
• Developing study-specific start-up plans and essential document review criteria.
• Partnering with site CRAs to ensure alignment in communication and secure site review.
• Customizing Patient Information Sheets and Informed Consent Forms.
• Coordinating document translations.
• Maintaining communication with key functions such as Feasibility, Clinical Operations, Project Management, Regulatory, and Site Contracts management.
• Acting as a Subject Matter Expert (SME) for site-level critical path data points.
• Supporting budget negotiations and investigator contracts.
• Assessing investigator interest in potential studies.
• Keeping updated on local clinical trial laws and regulations.
• Maintaining audit/inspection readiness and filing documents as per TMF plan.
• Supporting the clinical team in performing Pre-Study Site Visits.

Requirements:

• Bachelor’s degree in life sciences or related field, or Registered Nurse (RN) or equivalent.
• Minimum 1 year of experience as a Regulatory or Start-Up Specialist in a CRO or pharmaceutical/biotech industry.
• Experience in part II submissions for clinical trials in Belgium and/or Netherlands.
• Experience in ICF country adaptation for Belgium and/or Netherlands.
• Experience in site-level document collection for submissions and IP release for Belgium and/or Netherlands.
• Regulatory/SU experience covering Belgium and the Netherlands.
• Fluency in English, Dutch, and French.
• Strong communication and organizational skills.
• Experience using computerized information systems, electronic spreadsheets, word processing, and electronic mail.

The role offers:

• Opportunity to work remotely.
• Chance to contribute to ground-breaking cancer therapies.
• A supportive environment where employee contributions are valued.