Senior Regulatory and Start Up Specialist

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

📋 Description

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

• Responsible for overseeing country-level submissions and site activation processes by coordinating activities when multiple RSSs are involved in the country.

• Preparation of Clinical Trial Application Forms along with submission dossiers (initial and amendments/notifications) for submission to CA, EC, and other relevant local bodies in accordance with local requirements and within stipulated timelines to secure all necessary authorizations/approvals for conducting the Clinical Trial as per international and local/national regulations, company SOPs, and ICH-GCP principles.

• Engage with CA/EC for study-related purposes and manage responses to the CA/EC.

• Provide consistent updates on 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 when necessary.

• Maintain project plans, project trackers, and regulatory intelligence tools relevant to assigned duties and keep Regulatory Leadership informed.

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

• Collaborate with the assigned site CRA to ensure effective communication and site cooperation.

• Prepare, review, 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 translations for documents required for submission.

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

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

• When needed, participate in or support the negotiation of study budgets and the execution of investigator contracts under the guidance of the Site Contract Management department/designee.

• Stay informed on local clinical trial laws and regulations, and assist in disseminating this knowledge within PfM to ensure Clinical Trials are conducted in compliance with international and local/national regulations.

• Ensure audit/inspection readiness at all times and file documents according to the TMF plan and/or study-specific plans in the relevant TMF.

• May assist the clinical team with Pre-Study Site Visits.

• May support the feasibility group in reaching out to assess potential interest among investigators for upcoming studies.

• Will aid in the development of a country-specific Country Start-up summary and process flow that outlines timelines, risks, and success factors.

• Will contribute to the creation of training sessions to enhance Country Start-up knowledge and act as a Subject Matter Expert for inquiries.

• Will mentor staff on local country regulations, submissions, and internal procedures, as well as on PFM SSU-specific guidance and tools.

• Can take ownership of departmental process improvements/initiatives, including finalization, rollout, and periodic reviews.

• May engage with clients to provide activation readiness status updates, request documents or document reviews, and participate in proposal activities, including slide development and client presentations as required.

• May step into the role of Start Up Lead to drive site start-up activities to meet activation timelines for smaller or single-country studies or serve as a regional Start Up Lead for larger global studies under the direction of the global Start Up Lead.

• May interact with clients during Kick-off Meetings (KOMs), including slide development and client presentations as necessary.

⛳️ 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 combination of education, training, and experience.

• 5 years or more experience as a Regulatory or Start Up specialist in either a CRO or pharmaceutical/biotech industry, or relevant experience demonstrating competencies.

• Exceptional communication and organizational skills are essential.

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

• Fluency in English and Turkish.

• Ability to prioritize workload effectively to meet deadlines.

• Experience in driving cross-functional activities, coordinating, and overseeing a team.

🏝️ Benefits

• Competitive salary

• Flexible working hours

• Professional development opportunities