Regulatory and Site Start Up Specialist

Job Description

As a Regulatory and Site Start Up Specialist, you will ensure the timely and high-quality delivery of site activation readiness within your assigned country/sites, proactively identifying and mitigating potential risks. Key responsibilities include preparing Clinical Trial Application Forms and submission dossiers for Competent Authorities and Ethics Committees, adhering to local requirements and timelines to secure necessary authorizations/approvals. You will interact with regulatory bodies, provide regular updates to the Start Up Lead and Project Team, and maintain project plans and regulatory intelligence tools. Additionally, you will support the development of study-specific start-up plans, customize patient information sheets, and coordinate document translations. Collaboration with key functions like Feasibility, Clinical Operations, and Site Contracts is crucial for project success. You will also act as a subject matter expert for site-level critical path data, participate in budget negotiations, and stay updated on local clinical trial regulations to ensure compliance and audit readiness. Your role may also involve supporting pre-study site visits.

Qualifications

1. Bachelor’s degree in life sciences or a related field (ideally in a scientific or healthcare discipline), or Registered Nurse (RN) or equivalent combination of education, training, and experience. 2. A qualification in Pharmacy/ work experience as a Pharmacist would be highly beneficial. 3. At least one year of experience as a Regulatory or Start Up specialist (or comparable role) in either a CRO or pharmaceutical/ biotech industry or equivalent, relevant experience and/or demonstrated competencies. 4. Strong communication and organizational skills are essential. 5. Experience using computerized information systems, electronic spreadsheets, word processing, and electronic mail is required. 6. Fluency in English.

Benefits

- Competitive salary - Health insurance - Paid time off - Remote work flexibility