Regulatory and Start Up Specialist

• Deliver timely and high-quality site activation readiness for assigned countries/sites and foresee and mitigate risks
• 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, project 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 required 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 regarding status and deliverables
• Maintain site-level critical path data for site activation, including authority and ethics committee timelines, contracts, and budget negotiation requirements
• Support study budget negotiations and execution of investigator contracts
• Support feasibility site outreach
• Maintain knowledge of local clinical trial laws and regulations and distribute regulatory knowledge within PFM
• Maintain audit and inspection readiness and file documents according to TMF plans
• Support Pre-Study Site Visits when required
• Cover regulatory submissions and site contract and budget negotiation in Germany, Austria, and Switzerland

• 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
• Experience with 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
• Strong communication and organizational skills
• 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