Regulatory and Start Up Specialist

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

📋 Description

• Accountable for ensuring timely and quality delivery of site activation readiness within the designated countries/sites while identifying and mitigating potential risks.

• Preparation of Clinical Trial Application Forms along with the compilation of submission dossiers (initial and amendments/notifications) for submission to Competent Authorities, Ethics Committees, and other relevant local entities in accordance with local requirements and within specified timelines to secure all necessary authorizations/approvals for conducting Clinical Trials in compliance with international and local/national regulations, company SOPs, and ICH-GCP principles.

• Engage with Competent Authorities and Ethics Committees for study-related purposes and manage responses to these entities.

• Provide regular updates regarding CA and EC submissions to the Start Up Lead and/or Regulatory Lead assigned to the study, as well as to the Project Manager/Project Team.

• Maintain project plans, project trackers, and regulatory intelligence tools related to assigned duties, ensuring Regulatory Leadership is kept informed.

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

• Collaborate with the assigned site CRA to ensure effective communication, secure site reviews, and manage the collection of essential documents needed for site activation/IMP release.

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

• Oversee and facilitate the translation and coordination of document translations.

• Maintain communication with other key functions involved in country start-up, such as Feasibility, Clinical Operations, Project Management, Regulatory, and Site Contracts management groups, regarding project-specific status and deliverables.

• Act as a Subject Matter Expert (SME) for collecting and maintaining site-level critical path data points related to Site Activation, including but not limited to Competent Authority and local IRB/Ethics Committee timelines, site contracts, and budget negotiation requirements, ensuring timely site activation for assigned sites in the country.

• When necessary, assist in negotiating study budgets and executing investigator contracts under the guidance of the Site Contract Management department or its designee.

• May assist the feasibility group in site outreach to evaluate potential investigator interest in a study.

• Stay updated on local clinical trial laws and regulations, helping to disseminate this knowledge within PFM to ensure Clinical Trials are conducted in compliance with international and local/national regulations.

• Keep audit/inspection readiness at all times and organize documents according to the TMF plan and/or study-specific plans in the appropriate TMF.

• May support the clinical team by conducting Pre-Study Site Visits.

⛳️ Requirements

• Bachelor's degree in life sciences or a related field (preferably in a scientific or healthcare discipline), or Registered Nurse (RN), or an equivalent mix of education, training, and experience.

• A qualification in Pharmacy or experience as a Pharmacist would be highly advantageous.

• Proven experience in contract and budget negotiations.

• Ideally possess experience as a Regulatory or Start-Up specialist within a CRO or the pharmaceutical/biotech industry, or equivalent relevant experience and/or demonstrated competencies.

• Excellent communication and organizational abilities.

• Proficiency in using computerized information systems, electronic spreadsheets, word processing, and electronic mail is required.

• Fluency in English.

🏝️ Benefits

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• Equal Opportunity Employer