Regulatory and Site Start Up Specialist

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

📋 Description

• Ensure timely and high-quality readiness for site activation in designated countries/sites while mitigating risks.

• Prepare Clinical Trial Application forms and submission dossiers for Competent Authorities, Ethics Committees, IRBs, and other relevant local entities.

• Engage with Competent Authorities and Ethics Committees, addressing their responses effectively.

• Provide consistent submission updates to Start Up/Regulatory Leads, Project Managers, and Project Teams.

• Maintain project plans, trackers, and tools for regulatory intelligence.

• Assist in developing study-specific start-up plans, IMP release requirements, and essential document review criteria.

• Collaborate with site CRAs to ensure effective communication and site cooperation.

• Prepare, review, and manage essential documents required for site activation and IMP release.

• Tailor country/site-specific Patient Information Sheets and Informed Consent Forms.

• Oversee document translations.

• Coordinate with Feasibility, Clinical Operations, Project Management, Regulatory, and Site Contracts teams.

• Maintain critical-path data for site activation, including authority and IRB/EC timelines, contracts, and budget negotiation needs.

• Assist in study budget negotiations and execution of investigator contracts as necessary.

• Support feasibility site outreach when required.

• Stay informed about local clinical trial laws and regulations, sharing regulatory knowledge internally.

• Ensure audit/inspection readiness and organize documents in accordance with TMF and study-specific plans.

• Aid in Pre-Study Site Visits, process improvement initiatives, training, and mentoring.

• Carry out additional responsibilities as assigned by management.

⛳️ Requirements

• Bachelor’s degree in life sciences or a related field, or a Registered Nurse (RN), or an equivalent combination of education, training, and experience.

• At least 1 year of experience as a Regulatory or Site Start-Up Specialist, or a similar role within a CRO or pharmaceutical/biotech industry, or equivalent relevant experience and/or demonstrated competencies.

• Excellent communication and organizational abilities.

• Proficient in using computerized information systems, electronic spreadsheets, word processing, and electronic mail.

• Fluency in English and, in non-English-speaking countries, proficiency in the local language of the position’s location.

• Candidates must be legally authorized to work in the country of employment without the need for employer sponsorship.

• Relevant regulatory and site start-up experience specific to the country is preferred.

• Experience with milestone tracking tools/systems is preferred.

• Ability to prioritize tasks effectively to meet deadlines is preferred.

• An advanced degree in medical or life sciences, RAC certification, or a Master’s in Regulatory Science is preferred.

🏝️ Benefits

• Regular full-time employment status.

• Equal opportunity employment.

• Reasonable accommodations during the application process.