Regulatory and Site Start Up Specialist

• Deliver timely and high-quality site activation readiness within assigned countries/sites and foresee and mitigate risks
• Prepare Clinical Trial Application forms and submission dossiers for Competent Authorities, Ethics Committees, IRBs, and other applicable local bodies
• Interact with Competent Authorities and Ethics Committees and handle responses
• Provide regular submission updates to Start Up/Regulatory Leads and Project Managers/Project Teams
• Maintain project plans, project trackers, and regulatory intelligence tools
• Support development of study-specific start-up plans, IMP release requirements, and essential document review criteria
• Partner with assigned site CRAs to align communication and secure site collaboration
• Prepare, review, and manage essential documents required for site activation and IMP release
• Customize country/site-specific Patient Information Sheets and Informed Consent Forms
• Facilitate document translations and coordinate translation activities
• Maintain communication with Feasibility, Clinical Operations, Project Management, Regulatory, and Site Contracts teams
• Act as subject matter expert for site-level critical-path and site-activation data points
• Support study budget negotiations and investigator contract execution when required
• Support feasibility site outreach when needed
• Maintain current knowledge of local clinical trial laws and regulations and distribute knowledge within the company
• Maintain audit/inspection readiness and file documents according to TMF and study-specific plans
• Support Pre-Study Site Visits when needed
• Support process improvement initiatives, training, and mentoring
• Perform other duties assigned by management

• Bachelor’s degree in life sciences or related field, or Registered Nurse (RN), or equivalent combination of education, training, and experience
• 1 year or more as a Regulatory or Site Start-Up specialist or comparable role in a CRO, pharmaceutical, or 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, for non-English-speaking countries, the local language of the country where the position is based
• Candidates must be legally authorized to work in the country of employment without employer sponsorship
• Preferred: relevant regulatory and site start-up experience for the particular country
• Preferred: experience using milestone tracking tools/systems
• Preferred: ability to prioritize workload to meet deadlines
• Preferred: advanced degree in medical or life sciences, RAC certification, or Master’s in Regulatory Science

• Regular full-time employment
• Equal Opportunity Employer
• Reasonable accommodation available for applicants with disabilities