Regulatory and Start Up Specialist

• Deliver timely and high-quality site activation readiness for assigned countries and sites
• Prepare Clinical Trial Application forms and submission dossiers for Competent Authorities, Ethics Committees, and other local bodies
• Interact with Competent Authorities and Ethics Committees and handle responses
• Provide submission updates to Start Up Leads, Regulatory Leads, Project Managers, and project teams
• Maintain project plans, trackers, and regulatory intelligence tools
• Support study-specific start-up plans, IMP release requirements, and essential document review criteria
• Coordinate with assigned site CRAs to align communication and secure sites
• Review and manage essential documents for site activation and IMP release
• Customize country/site-specific Patient Information Sheets and Informed Consent Forms
• Coordinate document translations
• Communicate with Feasibility, Clinical Operations, Project Management, Regulatory, and Site Contracts teams
• Maintain site-level critical-path data for regulatory, ethics committee, contract, and budget requirements
• Support study budget negotiations and investigator contract execution
• Support feasibility site outreach
• Maintain knowledge of local clinical trial laws and regulations and share knowledge within Precision for Medicine
• Maintain audit and inspection readiness and file documents in the relevant TMF
• Support Pre-Study Site Visits when required

• Bachelor’s degree in life sciences or related field, or Registered Nurse (RN), or equivalent combination of education, training, and experience
• At least 2 years of relevant experience
• Previous experience as a Regulatory or Start Up Specialist in 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
• Fluency in English and German
• Qualification in Pharmacy or work experience as a Pharmacist highly beneficial
• Relevant regulatory and site start-up experience preferred
• Experience in site contract and budget negotiation preferred
• Experience using milestone tracking tools/systems preferred
• Advanced degree in medical or life sciences, RAC certification, or Master’s in Regulatory Science preferred

• Regular full-time employment
• Remote work arrangement
• Equal opportunity employment
• Reasonable accommodation support for applicants with disabilities